BD Nano Ultra-FineRecalls & reported problems across all models
Becton Dickinson Pen Limited · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 605
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 2 models of BD Nano Ultra-Fine by Becton Dickinson Pen Limited in the FDA's device registry (GUDID). Together they are named in 605 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2020 and Sep 30, 2026 — classified as 16 injuries, 589 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (443 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Nano Ultra-Fine problems
Device problems
- Failure to Deliver443
- Misconnection53
- Defective Device42
- Break30
- Device Markings/Labelling Problem22
- Complete Blockage20
- Leak/Splash14
- Packaging Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions333
- No Consequences Or Impact To Patient193
- No Known Impact Or Consequence To Patient65
- No Patient Involvement17
- Hyperglycemia12
- Needle Stick/Puncture11
- Foreign Body In Patient5
- No Information2
BD Nano Ultra-Fine models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Nano Ultra-Fine 320122Needle, hypodermic, single lumen601 reports
- BD Nano Ultra-Fine 320883Needle, hypodermic, single lumen4 reports
Recent BD Nano Ultra-Fine adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Becton Dickinson Pen Limited products
All Becton Dickinson Pen Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page