BD Nano Ultra-Fine 320122Recalls & reported problems

Summary

The FDA's MAUDE database contains 601 adverse event reports that list this exact device (DI 00382903201228), received between Jan 28, 2020 and Sep 30, 2026 — classified as 16 injuries, 585 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (440 reports).

1 other recall cover devices cleared under the same FDA submission (K213478); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 601 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947536 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample. This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947435 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947204 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947079 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946844 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946684 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sampleThis intake record was reviewed as part of CAPAs #PR-(b)(4) and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures (b)(6), and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6)-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946477 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946348 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946254 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample. This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945887 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sampleThis intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6) 17-Sep-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945684 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945418 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC. Lot # 4142007.Catalog# 320122. Date of Event Unknown. Sample Status Awaiting sample.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6), 17-Sep-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945275 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945202 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944929 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944820 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944658 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944502 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943585 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943298 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943241 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943131 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943083 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  Consumer Reported found from this box 20-25 pen needles that clogged during the flow check. Informed caller of Non patient end review and placement. DC Lot # 4142007Catalog# 320122 Date of Event Unknown Sample Status Awaiting sample____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; twenty-four additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Payam Pasandi 17-Sep-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942974 ↗
• MalfunctionSep 28, 2026Failure to Deliver

  Consumer husband Reported wife finding 10 percent of this box to clog during the flow check. DC Lot # 2111297Catalog# 320122Date of Event unknown Sample Status Discard

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913802 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213478. One submission often covers many models, so check the product and lot details in each record.

• Z-3180-2026 · Jul 26, 2023 · Open, Classified
  EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100