BD Ultra-Fine 328466Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00382908466035), received between Oct 27, 2017 and Sep 28, 2026 — classified as 7 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (43 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 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924244 ↗
• MalfunctionSep 24, 2026Failure to Deliver

  Consumer left voicemail requesting a call back regarding a problem she is having with the syringes. Consumer stated, she could not draw her insulin.3 syringes affected.Lot: 3332023.Catalog: 328466.Date of Event: Unknown.Samples: No CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882981 ↗
• MalfunctionSep 24, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882508 ↗
• MalfunctionApr 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHARMACIST CALLED IN TO GET ASSISTANCE WITH DETERMINING THE EXPIRATION DATE BASED ON THE LOT NUMBER. STATED, SHE DID NOT SEE AN EXPIRATION DATE ON THE BOX. STATED, THE BOX WAS OPENED AND SHE THINKS SOME WERE GIVEN OUT. DID NOT LOOK INSIDE TO COUNT THE PACKAGES. LOT: 5159577. CATALOG: 328466. SAMPLES: NO-WILL BE DISCARDING THEM. SEE RELATED CASES (B)(4).

  Patient problems: Hyperglycemia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21915026 ↗
• MalfunctionApr 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  HOLD FOR NG. 4/25/2025 HCP EMAIL COMMENTS. NOT KNOWING DATE OF EXP OF PRODUCTS. DATES MISSING FROM BOX. HCP CHECKING ON DATES. EMAIL DOES NOT STATE IF ITEMS WERE USED. 1. BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE, CAPACITY: ½ ML CC, LENGTH: 12.77 MM, GAUGE: 30G, LOT #: 5159577. 2. BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE, CAPACITY: 3/10 ML CC, LENGTH: 8MM, GAUGE: 31G, LOT #: 5195531. 3. BD INSULIN SYRINGES WITH THE BD ULTRA- FINE NEEDLE, CAPACITY: 1 ML CC, LENGTH: 8MM, GAUGE: 31G, LOT #: 4349670. EMAIL REPLY TO THIS CASE. HI TEAM, PLEASE SEE EMAIL BELOW. THANKS, (B)(6) FROM: CUSTOMER CARE SENT: MONDAY, MARCH 24, 2025 3:40 PM TO: HCP INQUIRIES SUBJECT: FWD: YOU HAVE A REPLY - (B)(6) - FW: MEDICAL INQUIRY RESPONSE FOR: (B)(6). HELLO TEAM, PLEASE LOOK INTO THE FOLLOWING QUERY AND DO THE NEEDFUL. THANKS AND REGARDS, EMBECTA CUSTOMER SUPPORT, ON MON, MAR 24 4:06 PM , MEDICAL <[email protected]> WROTE: CUSTOMER CARE TEAM, THIS CAME THROUGH TO THE MEDICAL INFORMATION MAILBOX TODAY, WOULD EITHER OF YOU BE ABLE TO ADDRESS THEIR CONCERN AROUND EXPIRATION. (B)(6) SENT: MONDAY, MARCH 24, 2025 3:25 PM. TO: MEDICAL INFORMATION <[email protected]> SUBJ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860909 ↗
• MalfunctionJun 24, 2024Packaging Problem; Packaging Problem

  CONSUMER REPORTED FOUND FROM THIS BOX 4 PACKET OF SYRINGES THAT WERE NOT SEALED. SYRINGES FELL TO THE FLOOR. SHE LATER USED THE SYRINGES. DC. LOT # 3353016. CATALOG# 328466. DATE OF EVENT UNKNOWN ABOUT A MONTH AGO. SAMPLE STATUS AWAITING SAMPLE - BAGS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593906 ↗
• MalfunctionMay 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCOUNT - (B)(6) MATERIAL - SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS MATERIAL# - 328466 MATERIAL LOT# - 3332023 COMPLAINT DESCRIPTION - I HAVE A CUSTOMER THAT HAS A PRODUCT COMPLAINT ON ITEM 328466 THAT WE PURCHASE FROM YOU. IT WOULD BE LOT 3332023, AND THEY ARE STATING ¿DR FOUND PLASTIC INSIDE SYRINGE ON SEVERAL OF THESE SYRINGES¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293855 ↗
• MalfunctionMar 5, 2024Volume Accuracy Problem; Volume Accuracy Problem

  CONSUMER REPORTED THAT THE SCALE PRINT IS CROOKED. CONSUMER ALSO REPORTED RUBBER STOPPER IS SLANTED IN THE BARREL. CONSUMER REFUSED TO SEND IN SAMPLES, STATED THAT HE DID THIS BEFORE AND THE PROBLEM HAS NOT BEEN FIXED. CONSUMER DISCONNECTED THE CALL. LOT #: 3202457. CATALOG #: 328466. DATE OF EVENT: UNKNOWN. SAMPLES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837192 ↗
• MalfunctionMar 5, 2024Leak/Splash; Leak/Splash

  CONSUMER REPORTED THAT THE SCALE PRINT IS CROOKED. CONSUMER ALSO REPORTED RUBBER STOPPER IS SLANTED IN THE BARREL. CONSUMER REFUSED TO SEND IN SAMPLES, STATED THAT HE DID THIS BEFORE AND THE PROBLEM HAS NOT BEEN FIXED. CONSUMER DISCONNECTED THE CALL. LOT #: 3202457 CATALOG #: 328466 DATE OF EVENT: UNKNOWN SAMPLES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836815 ↗
• MalfunctionDec 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. CONSUMER DOES NOT RE-USE. CONSUMER REFUSED REPLACEMENT BUT SENDING SAMPLES. LOT #: 3065255 CATALOG #: 328466 DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350358 ↗
• MalfunctionNov 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED 4 OF THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD FOREIGN MATTER. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: CONSUMER ADULT SON REPORTED FINDING A CLEAR LIQUID COMES OUT OF NEEDLE WHEN PRESSED PLUNGER ON (B)(4) SYRINGES. MOM DISCARDED THE SYRINGE. WILL SEND SEALED PACKET FROM THIS BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143072 ↗
• MalfunctionAug 31, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT 2 OF THE BD ULTRA-FINE¿ INSULIN SYRINGES WERE MIXED WITH ANOTHER PRODUCT TYPE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED MIXED PRODUCT. SHE STATED THAT THERE WERE 2 PACKAGES OF 8MM SYRINGES MIXED IN HER BOX OF 12.7MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661578 ↗
• MalfunctionAug 30, 2023Defective Component; Inaccurate Delivery; Difficult to Advance; Defective Component; Inaccurate Delivery; Difficult to Advance

  IT WAS REPORTED THAT WHILE USING THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE STOPPER WAS MISALIGNED, MAKING THE PLUNGER MOVEMENT DIFFICULT AND UNABLE TO DELIVER MEDICATION. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, SHE WAS ABLE TO DRAW UP HER INSULIN BUT WHEN SHE TRIED TO TAKE THE INJECTION, THE "STOPPER" BECAME STIFF AND SHIFTED INSIDE THE BARREL MAKING IT DIFFICULT TO PUSH THE PLUNGER ROD. STATED, ONLY A SMALL AMOUNT OF INSULIN WENT INTO THE INJECTION SITE. STATED, THE FIRST UNIT MARKING ON THE BARREL VARIOUS BETWEEN SYRINGES. STATED, SHE IS CONCERNED WITH DRAWING UP TOO MUCH OR TOO LITTLE INSULIN DUE TO THE INCONSISTENCIES WITH SCALE MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650964 ↗
• MalfunctionAug 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDL HAD SCALE MARKING ISSUES. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, SHE WAS ABLE TO DRAW UP HER INSULIN BUT WHEN SHE TRIED TO TAKE THE INJECTION, THE "STOPPER" BECAME STIFF AND SHIFTED INSIDE THE BARRELL MAKING IT DIFFICULT TO PUSH THE PLUNGER ROD. STATED, ONLY A SMALL AMOUNT OF INSULIN WENT INTO THE INJECTION SITE STATED, THE FIRST UNIT MARKING ON THE BARREL VARIOUS BETWEEN SYRINGES. STATED, SHE IS CONCERNED WITH DRAWING UP TOO MUCH OR TOO LITTLE INSULIN DUE TO THE INCONSISTENCIES WITH SCALE MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647286 ↗
• MalfunctionAug 29, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDL HAD DIFFICULTY MOVING THE PLUNGER. REPORT 3 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, SHE WAS ABLE TO DRAW UP HER INSULIN BUT WHEN SHE TRIED TO TAKE THE INJECTION, THE "STOPPER" BECAME STIFF AND SHIFTED INSIDE THE BARRELL MAKING IT DIFFICULT TO PUSH THE PLUNGER ROD. STATED, ONLY A SMALL AMOUNT OF INSULIN WENT INTO THE INJECTION SITE STATED, THE FIRST UNIT MARKING ON THE BARREL VARIOUS BETWEEN SYRINGES. STATED, SHE IS CONCERNED WITH DRAWING UP TOO MUCH OR TOO LITTLE INSULIN DUE TO THE INCONSISTENCIES WITH SCALE MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647285 ↗
• MalfunctionJan 26, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE CANNULA LENGTH WAS INSUFFICIENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY REPORTED FOUND THE NEEDLES TO BE OF DIFFERENT LENGTHS WITHIN THIS BOX. THEIR PATIENT RETURNED TO THE STORE. THEY DID NOT PROVIDE REPLACEMENT BOX TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251471 ↗
• MalfunctionJan 26, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PIERCED THROUGH THE SHIELD AFTER THE CONSUMER RECAPPED IT. THIS OCCURRED WITH 2 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED GEST DIABETIC RESHIELDED SYRINGE AFTER INJECTION AND STUCK HER FINGER WHEN NEEDLE WENT THRU NEEDLE SHIELD. 2 TIMES, 2 DIFFERENT SYRINGES FROM THIS BOX. ADVISED CALLER TO NOT RESHIELD THE SYRINGES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251035 ↗
• MalfunctionDec 30, 2022Crack; Crack

  IT WAS REPORTED THAT THE BARREL OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BARREL CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080732 ↗
• MalfunctionSep 28, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER CALLED TO INQUIRE ABOUT SYRINGE EXPIRATION DATE, STATED THAT THERE IS NO EXPIRATION DATE ON THE BOX. CONSUMER WAS NOT ABLE TO LOCATE A LOT#, SHE PROVIDED CONTROL#: 98916".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499834 ↗
• MalfunctionAug 4, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 6 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER NORMALLY LANDS ON ZERO BEFORE USE BUT NOW SHE IS NOTICING "STOPPER" IS SITTING ANYWHERE BETWEEN 0 AND 5. SCALE MARKINGS NOT ACCURATE ON BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163378 ↗
• MalfunctionApr 5, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SEEING CLEAR LIQUID IN THE BARREL OF SYRINGES PRIOR TO INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017376 ↗
• MalfunctionSep 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST STATED, HE NOTICED THE CLEAR LIQUID/FOREIGN MATTER ON NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529288 ↗
• MalfunctionAug 25, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS NOW THE SECOND BOX OF SYRINGES I HAVE PURCHASED THAT CONTAINS SYRINGES WITH INCONSISTENT MARKINGS. WE CANNOT INJECT A CONSISTENT INSULIN DOSE BECAUSE THE MARKINGS ARE NOT SAME ON ALL THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367079 ↗
• MalfunctionJul 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AT LEAST 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328466 BATCH NO: 3043392, 2339296. CONSUMER REQUESTED EXPIRATION DATE ON SYRINGES, STATED THAT THERE WAS NO EXPIRATION DATE ON THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100588 ↗
• MalfunctionMay 5, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD NO EXPIRATION DATE LISTED ON ITS LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BOX DOES NOT SHOW EXP DATE SHE HAS NOT USED FROM THIS BOX OUTSIDE OF A YEAR WHEN FIRST PURCHASED. HAS 8 BAGS IN BOX AND USING A PUMP. THESE SYRINGES ARE HER BACK UP AND FILLING SYRINGES. INFORMED FROM SCRIPT DATE AND LOT NUMBER THEY ARE EXPIRED. BOX DOES NOT HAVE EXPIRATION DATE ON IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778605 ↗