BD Nano Ultra-Fine Pen Needles, 32G x 4MM 320540Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903205400), received between Sep 25, 2018 and May 30, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE NANO¿ WAS DIFFICULT TO REMOVE FROM THE BASLAGAR PEN WITH THE OUTER COVER BECOMING LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED HAVING ISSUES REMOVING PEN NEEDLE FROM HER PEN. FIRST LOOSING THE OUTER COVER TO REMOVE IT WITH. INFORMED CALLER TO NOT STORE PEN NEEDLE ON HER BASLAGAR PEN AS SHE WAS DOING. ALSO NOT TO REUSE THE PEN NEEDLE AS SHE WAS DOING. NEW START TO INJECTING STARTED IN MARCH"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027367 ↗
• MalfunctionMar 24, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE BROKE AND INSULIN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 1 PEN NEEDLE TO POSSIBLE BREAK OFF IN SITE. COMPLETED THE INJECTION REMOVE PEN AWAY FROM SITE, HUMALOG RAN DOWN SITE AND NEEDLE NOT THERE."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893115 ↗
• MalfunctionAug 26, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 4 PEN NDL 32 G 4 MM 5B XTW BULK US W/EXPIRY EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT EXPIRATION DATES FOR PEN NEEDLE SAMPLE PACKS. STATED HE HAS 5 SAMPLE PACKS WITH NO EXPIRATION DATE ON THEM. STATED HE COULD NOT FIND A COPYRIGHT DATE OR MANUFACTURE DATE AND HE COULD NOT REMEMBER IF THESE WERE FROM 2007/2008 OR 2017/2018. ADVISED CONSUMER THAT WITHOUT A MANUFACTURE OR COPYRIGHT DATE, UNABLE TO CONFIRM THE YEAR. ADVISED CONSUMER THESE COULD BE EXPIRED. LOT # 7052840, LOT # FOR 2 BOXES: 8045794, LOT # 8144503, LOT #7012659, CAT # FOR ALL PACKS: 320540.

  Patient problems: No Patient Involvement

  MAUDE report 10457595 ↗
• MalfunctionJun 15, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON WAS DIFFICULT TO REMOVE FROM THE INSULIN PEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320540 BATCH NO: 8144593. IT WAS REPORTED THAT THE PEN NEEDLE WAS DIFFICULT TO REMOVE FROM INSULIN PEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156093 ↗
• MalfunctionMay 13, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON 5 PACKS OF PEN NEEDLES 32G 4MM 5B XTW 7CT CARTON IN LOT# 7052840, AND AN UNSPECIFIED NUMBER OF PACKS FROM LOT# 7012659, BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE OF CONSUMER CALLED TO CONFIRM IF SAMPLE PACKS OF BD PEN NEEDLES ARE STILL GOOD. STATED THERE IS NO EXPIRATION DATE ON ANY OF THE PACKS, HOWEVER CONFIRMED A COPYRIGHT DATE OF 2016 ON ALL SAMPLE PACKS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10053585 ↗
• InjuryOct 21, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING PRIMING THE INSULIN DID NOT FLOW AND CONSUMERS WAS HYPERGLYCEMIC AT THE TIME WITH A BD PEN NEEDLE 32G 4MM. THIS INSULIN NOT FLOWING DURING PRIMING OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS NO INSULIN FLOW DURING PRIMING AND BLOOD SUGAR WAS HIGH, CONSUMER WAS LEAVING INNER SHIELD ON WHEN PRIMING PEN NEEDLE. ADDITIONAL INFORMATION: CONSUMER IS NEW TO INJECTIONS. AFTER TROUBLESHOOTING, IT WAS DISCOVERED, CONSUMER WAS LEAVING THE INNER SHIELD ON WHEN PRIMING. WENT OVER INSTRUCTION ON HOW TO PRIME AND INJECT. CONSUMER NOW KNOWS HOW TO USE PEN NEEDLES. DIRECTED HER ALSO TO BD WEBSITE FOR TUTORIALS.

  Patient problems: Hyperglycemia

  MAUDE report 9215229 ↗
• MalfunctionFeb 6, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE HAD INCORRECT OR MISSING LABEL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312824 ↗
• MalfunctionSep 25, 2018Break

  IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ PEN NEEDLE THERE WAS AN ISSUE WITH NEEDLE BREAK DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905713 ↗