BD Nano 2nd Gen 320574Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00382903205745), received between Jan 28, 2023 and Sep 29, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (54 reports).

2 other recalls cover devices cleared under the same FDA submission (K212015); 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936794 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  I received a chat from a consumer about some needles having difficulty priming. Once I try another needle, it works fine. I have been averaging at least 15 needles per box that are unable to be used. I take 5 shots per day and this is getting very expensive, this has been going on for Months! I ignored the fact because I am recuperating from a broken kneecapWhen I attempt to prime the needle, nothing comes out. And I try many timesThe latest box is Ref 320574 and Lot 3087278_______________________________________________________________________________________________________________________________________________

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936693 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936430 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936299 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936053 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935434 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935104 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934361 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933650 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  I received a chat from a consumer about some needles having difficulty priming. Once I try another needle, it works fine. I have been averaging at least 15 needles per box that are unable to be used. I take 5 shots per day, and this is getting very expensive, this has been going on for Months! I ignored the fact because I am recuperating from a broken kneecapWhen I attempt to prime the needle, nothing comes out. And I try many timesThe latest box is Ref 320574 and Lot 3087278This intake record was reviewed as part of CAPAs #(b)(4) and #(b)(6) and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Needle Clog. 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) 14September2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930032 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929431 ↗
• MalfunctionSep 8, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674512 ↗
• MalfunctionMay 19, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED FOUND 4 PEN NEEDLES FROM THIS BOX TO CLOG DURING THE FLOW CHECK. DISCARDED 3 OF THE 4. HAS 1 PEN NEEDLE FROM TODAYS INJECTION TO SEND BACK. REVIEWED WITH THIS CALLER PROPER PLACEMENT OF NON-PATIENT END TO PEN, HE NOTED THE NON-PATIENT END NEEDLE TO BE BENT. (THIS IS THE ONE RETURNING) DATE OF EVENT 04.25.2025). LOT # 310174, CATALOG# 320574, DATE OF EVENT 04.25.2025 = 1, DATE OF EVENT UNKNOWN = 3, SAMPLE STATUS AWAITING SAMPLE = 1. TMAIK 24APRIL2025. CLARIFICATION. UPDATE 00024018, DATE OF EVENT IS 04.24.2025 = 1 PEN NEEDLE, LOT # 3101704.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044682 ↗
• MalfunctionMay 14, 2025Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  THE CONSUMER REPORTED THE NON-PATIENT END WILL NOT ATTACH TO THE INSULIN PEN STATED, SHE IS NOTICING THE NEEDLE AT THE NON-PATIENT END IS BENT AFTER TRYING TO ATTACH THE PEN NEEDLE. STATED, SHE IS EXPERIENCING PEN NEEDLE CLOG WHEN TRYING TO TAKE INJECTIONS. LOT: 3339367. CATALOG: 320574. DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021797 ↗
• MalfunctionMar 19, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. LOT #: 3179396 CATALOG #: 320574 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643870 ↗
• MalfunctionMar 13, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED WHEN PRIMING THE PEN NEEDLES, NO INSULIN COMES OUT. STATED, SHE ALWAYS TEST 2 UNITS LOT: 3283960, (POOR EYESIGHT) CATALOG: NANO PEN NEEDLE PER CONSUMER DATE OF EVENT: UNKNOWN SAMPLES: YES CL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595611 ↗
• MalfunctionFeb 3, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED FINDING DURING THE FLOW CHECK THE NEEDLE IS CLOGGED ON 13 PEN NEEDLES. INFORMED THIS CALLER PROPER PLACEMENT OF NON PATIENT END. LOT # 3290785, CATALOG# 320574, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293068 ↗
• MalfunctionJan 7, 2025Break; Failure to Deliver; Break; Failure to Deliver

  CONSUMER REPORTED WAS ABLE TO COMPLETE THE FLOW CHECK WITH THIS NEEDLE. HOWEVER, DURING THE INJECTION, THE NEEDLE STOPPED ALLOWING THE INSULIN TO FLOW, CLOGGED. REMOVED NEEDLE FROM LANTUS PEN AND COULD SEE THE NON-PATIENT END NEEDLE BROKE OFF IN PEN. NO INJURY TO CONSUMER. SHE HAS THE NEEDLE IN TAPE ALONG WITH HUB TO RETURN. (B)(6). LOT # 3017767. CATALOG# 320574. DATE OF EVENT DECEMBER 11, 2024. SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092458 ↗
• MalfunctionDec 10, 2024Failure to Deliver; Defective Device; Failure to Deliver; Defective Device

  CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. CONSUMER ALSO REPORTED NON-PATIENT END NEEDLE MISSING. SHE STATED THAT SHE NOTICED THE NEEDLES WERE MISSING WHEN SHE LOOKED INSIDE OF THE HUB AFTER REMOVING IT FROM THE PEN. CONSUMER DOES NOT RE-USE. LOT #: 3283960. CATALOG #: 320574. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893649 ↗
• MalfunctionNov 1, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. LOT #: 3179396. CATALOG #: 320574. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587186 ↗
• MalfunctionOct 22, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT PRIME, HE DOES NOT RE-USE. LOT #: 3052557; CATALOG #: 320574; DATE OF EVENT: UNKNOWN; SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506208 ↗
• MalfunctionOct 17, 2024Break; Break

  CONSUMER REPORTED, THE NON-PATIENT END BROKE OFF IN INSULIN PEN WHEN TRYING TO REMOVE PEN NEEDLE AFTER INJECTION. 1 PEN NEEDLE AFFECTED. NO INJURY TO REPORT; MAIL KIT AND REPLACEMENT BOX; EVENT DATE SEPT 21, 2024; SAMPLE STATUS AWAITING SAMPLE CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471141 ↗
• MalfunctionOct 10, 2024Failure to Deliver; Failure to Deliver

  SPOUSE OF CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER ALSO REPORTED NON PATIENT END NEEDLE BENT. ISSUES INVOLVE TWO DIFFERENT LOTS. CONSUMER DOES NOT PRIME, CONSUMER DOES NOT RE-USE. LOT #: 3115886, 3179396 CATALOG #: 320574 DATE OF EVENT: UNKNOWN SAMPLES AVAILABLE: SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417967 ↗
• MalfunctionOct 10, 2024Failure to Deliver; Failure to Deliver

  SPOUSE OF CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER ALSO REPORTED NON PATIENT END NEEDLE BENT. ISSUES INVOLVE TWO DIFFERENT LOTS. CONSUMER DOES NOT PRIME, CONSUMER DOES NOT RE-USE. LOT #: 3115886, 3179396. CATALOG #: 320574. DATE OF EVENT: UNKNOWN. SAMPLES AVAILABLE: SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417787 ↗
• MalfunctionOct 4, 2024Misconnection; Misconnection

  CONSUMER REPORTED FINDING THE NON PATIENT END HARD TO INSERT INTO THE PEN. CONSUMER REPORTED FINDING THE PATIENT END NOT SHARP AND PAINFUL TO INSERT INTO SITE. LOT # 3179397; CATALOG# 320574; DATE OF EVENT UNKNOWN; SAMPLE STATUS AWAITING SAMPLE UNUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212015. One submission often covers many models, so check the product and lot details in each record.

• Z-2424-2024 · Jun 18, 2024 · Open, Classified
  BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for
• Z-3179-2026 · Jul 26, 2023 · Open, Classified
  EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100