BD U-500 326730Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903267309), received between Mar 16, 2018 and Jul 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  VA REPORTED VIA EMAIL - FOUND TWO U-100 SYRINGES WITH A GREEN NEEDLE SHIELD IN A U-500 PACKET. LOT # 3058741. LOT # 1291172. CATALOG# 326730. DATE OF EVENT 06/02/2025. ASKING IS MAIL KIT SHOULD BE SENT TO THIS VA PHARMACIST. PLEASE LOOK INTO THIS REQUEST. REGARDS, CUSTOMER SUPPORT ON TUE, JUN 3 6:56 AM , NAME REMOVED (B)(6) WROTE: GOOD AFTERNOON, I AM LOOKING TO CONNECT WITH SOMEONE AT BD/EMBECTA TO REVIEW A PRODUCT ISSUE WITH U-500 SYRINGES. WE WOULD LIKE TO CLARIFY IF THIS IS THE INTENDED DESIGN BY BD OR A SAFETY ISSUE WITH THE LOT. THE U-500 SYRINGES TYPICALLY HAVE A GREEN CAP WITH MARKINGS OF 25-250 AT 0.5ML. WE WOULD LIKE TO KNOW IF BD/EMBECTA HAS A GREEN TIP U-500 SYRINGE WITH THESE DIFFERENT MARKINGS OF 5-50 ¿ AND IF WE SHOULD ASSIST WITH A SAFETY REPORT FOR REVIEW/VALIDATION. RESPECTFULLY, (B)(6). FROM: (B)(4) CUSTOMER SUPPORT EMAIL TO CASE <[email protected]> SENT: MONDAY, JUNE 2, 2025 2:50 PM TO (B)(6). SUBJECT: [EXTERNAL] RE: U-500 PRODUCT SAFETY QUESTION. HELLO, BD IS UNABLE TO COMPLETE YOUR REQUEST AS THE PREVIOUS DIABETES CARE DIVISION OF BD WAS SEPARATED IN 2022 INTO A SEPARATE PUBLIC COMPANY CALLED EMBECTA CORP. AS PART OF THE SEPARATION, BD LICENSED THE USE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579339 ↗
• MalfunctionJul 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  (B)(6) 22JULY2025. UPDATE FROM (B)(6). UPDATE (B)(4) BASED UPON ORIGINAL EMAIL COMPLAINT, THE EVENT DATE HAS BEEN CONFIRMED AS JUNE 2, 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384871 ↗
• MalfunctionApr 15, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 0.5ML 31G X 6MM U-500 INSULIN SYRINGE EXPERIENCED THE NEEDLE PIERCING THROUGH THE CAP/SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 326730 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN RECAPPING THE NEEDLE, IT IS EASY TO REDIRECT THE NEEDLE TIP TO PIERCE THE OUTER CAP LEADING TO A NEEDLE STICK. VERBATIM: WHEN DRAWING UP AND RECAPPING U-500 INSULIN SYRINGES, IT IS QUITE EASY TO REDIRECT THE NEEDLE TIP TO PIERCE THE OUTER CAP LEADING TO A NEEDLE STICK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514302 ↗
• MalfunctionAug 30, 2018Break; Component Missing; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE, THE CONSUMER REPORTED THAT SOME SYRINGES ARE MISSING THE PLUNGER ROD, MISSING NEEDLE, MISSING PLUNGER CAP, ONE PLUNGER ROD WAS FOUND TO BE BROKEN AND ONE SYRINGE WAS FOUND TO HAVE BLACK FOREIGN MATERIAL IN THE BARREL THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7833609 ↗
• MalfunctionMay 23, 2018Crack

  IT WAS REPORTED THAT A CONSUMER FOUND THE BARREL CRACKED ON A BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538958 ↗
• MalfunctionMar 16, 2018Defective Component

  IT WAS REPORTED THAT THE CONSUMER RECEIVED BD¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE(S) THAT WERE NOT SEALED AND SEEMED TO BE TAMPERED WITH. THE PRODUCT WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345743 ↗