BD Safe-Clip 328235Recalls & reported problems

Summary

The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 00382903282357), received between May 1, 2018 and Nov 8, 2024 — classified as 1 injury, 267 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (214 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 268 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED USING THE SAFE CLIP WITH A 4MM PEN NEEDLE, INJECTING 4 TIMES A DAY. THE SAFE CLIPS ON AVERAGE CLIP 520 PEN NEEDLES. LOT # 3108001. LOT # UNKNOWN. CATALOG# 328238. DATE OF EVENT UNKNOWN. SAMPLE STATUS DISCARD. CALLER DECLINED MAILING KIT. INFORMED CALLER ITEM CEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641942 ↗
• MalfunctionNov 8, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED USING THE SAFE CLIP WITH A 4MM PEN NEEDLE, INJECTING 4 TIMES A DAY. THE SAFE CLIPS ON AVERAGE CLIP 520 PEN NEEDLES. LOT # 3108001; LOT # UNKNOWN; CATALOG# 328238; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD. CALLER DECLINED MAILING KIT. INFORMED CALLER ITEM CEASED. DC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641940 ↗
• MalfunctionSep 13, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED, DEVICE IS NOT CLIPPING ANYMORE. STATED, SHE WAS ONLY ABLE TO CLIP 20 TIMES STATED, SHE IS CLIPPING 25G NEEDLE LOT: 1179175 CATALOG: 328235 DATE OF EVENT: 2024-20-08 SAMPLES: YES SENDING SHARPS CONTAINER AS REPLACEMENT. CL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217284 ↗
• MalfunctionAug 15, 2024Failure to Cut; Failure to Cut

  CONSUMER LEFT VOICEMAIL REPORTING THAT THE BD SAFE CLIP NEEDLE CLIPPER IS NOT CLIPPING. I RETURNED CONSUMER'S CALL AND HE STATED THE SAME. HE SAID THAT HE HAD PURCHASED THE SAFE CLIP ABOUT 2 WEEKS AGO AND IT IS NO LONGER CLIPPING THE NEEDLES. I ADVISED CONSUMER THAT THE SAFE CLIPS HAVE BEEN DISCONTINUED AND ARE NO LONGER AVAILABLE. CONSUMER REFUSED TO PROVIDE HIS MAILING ADDRESS, SAID THERE IS NO NEED FOR MAIL KIT IF THE PRODUCT CANNOT BE REPLACED. LOT #: 5211373; CATALOG #: 328235; DATE OF EVENT: UNKNOWN; SAMPLES: UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991180 ↗
• MalfunctionJun 21, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED THAT THE SAFE CLIP NEEDLE CLIPPER IS JAMMED. HE STATED THAT HE USED IT FOR OVER A YEAR BUT HE KNOWS THAT HE HAS NOT CLIPPED 1500 NEEDLES. HE SAID THE NEEDLE CLIPPER IS NOT FULL. LOT #: 2171002. CATALOG #: 328235. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584504 ↗
• MalfunctionMay 3, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED THIS SAFECLIP CLIPPED ONLY 77 PEN NEEDLES, 32G. WILL NO LONGER CLIP HER 2ND GEN PEN NEEDLES. LOT # 2054218. CATALOG# 328235. DATE OF EVENT (B)(6) 2024. SAMPLE STATUS AWAITING SAMPLE DC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243459 ↗
• MalfunctionApr 19, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER IS NOT WORKING, STATED THAT THE NEEDLE WILL NOT GO INTO THE SAFE CLIP. CONSUMER STATED THAT SHE HAD THE SAFE CLIP FOR AWHILE BUT IT IS NOT FULL BUT IT JUST STOPPED WORKING. LOT #: 1308206. CATALOG #: 328235. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147124 ↗
• MalfunctionApr 15, 2024Failure to Cut; Failure to Cut

  PET OWNER REPORTED HAS 1 SAFE CLIP DEVICE THAT WILL NOT CLIP THE 31G NON BD INSULIN SYRINGE. LOT # 2031001. CATALOG# 328235. DATE OF EVENT 03-20-2024. SAMPLE STATUS AWAITING SAMPLE =(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112373 ↗
• MalfunctionApr 15, 2024Failure to Cut; Failure to Cut

  CONSUMER LEFT VOICEMAIL REPORTING THAT THE BD SAFE CLIP NEEDLE CLIPPER IS NOT WORKING. CONSUMER DID NOT PROVIDE A CONTACT PHONE NUMBER. NO ADDITIONAL INFORMATION TO PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112028 ↗
• MalfunctionApr 15, 2024Failure to Cut; Failure to Cut

  PET OWNER REPORTED HAS 1 SAFE CLIP DEVICE THAT WILL NOT CLIP THE 31G NON BD INSULIN SYRINGE. LOT # 2031001. CATALOG# 328235. DATE OF EVENT 03-21-2024. SAMPLE STATUS AWAITING SAMPLE =(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111753 ↗
• MalfunctionApr 8, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED HE WAS USING THE BD SAFE CLIP WITH DEXCOM INFUSION SET NEEDLE. THE NEEDLE WOULD NOT CLIP OFF WITH THE SAFE CLIP DEVICE, WAS USING FOR ABOUT 6 MONTHS. NO LONGER WILL CLIP NEEDLE. LOT # 3005001. CATALOG# 328235. DATE OF EVENT UNKNOWN. SAMPLE STATUS DISCARD. CALLER DID NOT WANT TO LEAVE FURTHER INFORMATION. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067776 ↗
• MalfunctionFeb 27, 2024Failure to Cut; Failure to Cut

  CONSUMER REPORTED, SHE USED THE DEVICE 8 TIMES AND NOW IT NO LONGER WORKS. STATED, SHE CANNOT PUSH THE NEEDLE INTO THE HOLE TO CLIP. LOT: 3011001. CATALOG: 328235. DATE OF EVENT: UNKNOWN. SAMPLE: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790209 ↗
• MalfunctionFeb 27, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THE BD SAFE-CLIP¿ IS NOT WORKING, THIS OCCURRED WITH TWO (2) CLIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I'VE TRIED TO TALK TO MY PHARMACY, BUT THEY CAN'T NOT EXPLAIN. I'VE HAD TWO CLIPPERS AND BOTH STOP WORKING AFTER A WHILE, LESS THAN A YEAR. IT SHOULD BE VALID FOR 1500 NEEDLES, IN MY CASE, THAT WILL BE 4 YEARS? THEY DON'T EVEN LAST A YEAR, THAT MEANS LESS THAN 365 NEEDLES AM I DOING SOMETHING WRONG?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788587 ↗
• MalfunctionDec 15, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE INITIAL REPORTER THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE WAS NOT CLIPPING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: NEEDLE CLIPPERS (LOT#3003001) PATIENT OBTAINED FROM RETAIL PHARMACY APPROX 2-3 MONTHS AGO ARE NOT CUTTING NEEDLE TIPS OFF AS PER DESIGN. SEEMS TO BE BENDING THE TIP, SOMETIMES BREAKING IT THROUGH BENDING FORCE, OTHER TIMES NOT AT ALL. ALSO SEEMS TO BE A NEEDLE TIP JAMMED INSIDE NEEDLE ENTRY POINT OF CLIPPERS (UNABLE TO REMOVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341408 ↗
• MalfunctionNov 17, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT WHILE USING THE BD SAFE-CLIP¿ IT WOULD NOT CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CONSUMER REPORTED THAT HIS SAFE CLIP NEEDLE CLIPPER IS NOT CLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159742 ↗
• MalfunctionNov 14, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE IS NOT CLIPPING. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED THAT HIS SAFE CLIP NEEDLE CLIPPER IS NOT CLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133941 ↗
• MalfunctionSep 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ RATTLED AS IF IT ALREADY HAD CLIPPED NEEDLES INSIDE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECENTLY PURCHASED BD SAFE-CLIP: REF #328235 LOT #2235002 ...AND THE ONE I GOT AND OPENED TODAY: 1) ALREADY HAS A BIOHAZ STICKER ON IT, AND 2) RATTLES- LIKE IT ALREADY HAS CLIPPED NEEDLES IN IT SUBSEQUENTLY, I WENT ONLINE AND LOOKED UP PRODUCT REVIEWS. APPARENTLY, THERE ARE SEVERAL CUSTOMERS WHO HAVE COMPLAINED ABOUT THE EXACT SAME THING. WHAT'S GOING ON? ARE WE GETTING USED BIOHAZARD SHARPS CONTAINERS SENT OUT TO US? I ALSO WORK IN A XXX QC LABORATORY AND WE ALWAYS RELY ON BD TO SUPPLY OUR SYRINGES, NEEDLES, ETC. FOR BACTERIAL ENDOTOXIN ASSAYS AND SUCH. WE HAVE NEVER HAD ANY PROBLEM WITH THE LAB SHIPMENTS. ...SO, IT'S JUST REALLY WEIRD THAT THE DIRECT-TO-CONSUMER SALES ARRIVE IN SUCH CONSISTENTLY QUESTIONABLE CONDITIONS. ...OR, THE THING JUST RATTLES AND THERE AREN'T ANY STRANGER'S USED NEEDLES IN THERE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796008 ↗
• MalfunctionSep 21, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ HAD A BIOHAZARD STICKER ON IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECENTLY PURCHASED BD SAFE-CLIP: REF #(B)(4), LOT #2235002. AND THE ONE I GOT AND OPENED TODAY: 2) RATTLES- LIKE IT ALREADY HAS CLIPPED NEEDLES IN IT. SUBSEQUENTLY, I WENT ONLINE AND LOOKED UP PRODUCT REVIEWS. APPARENTLY, THERE ARE SEVERAL CUSTOMERS WHO HAVE COMPLAINED ABOUT THE EXACT SAME THING. WHAT'S GOING ON? ARE WE GETTING USED BIOHAZARD SHARPS CONTAINERS SENT OUT TO US? I ALSO WORK IN A (B)(6) AND WE ALWAYS RELY ON BD TO SUPPLY OUR SYRINGES, NEEDLES, ETC. FOR BACTERIAL ENDOTOXIN ASSAYS AND SUCH. WE HAVE NEVER HAD ANY PROBLEM WITH THE LAB SHIPMENTS. SO, IT'S JUST REALLY WEIRD THAT THE DIRECT-TO-CONSUMER SALES ARRIVE IN SUCH CONSISTENTLY QUESTIONABLE CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795403 ↗
• MalfunctionSep 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ FAILED TO CUT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT HIS SAFE CLIP IS NOT CLIPPING. STATED THAT THE DEVICE STOPPED WORKING AFTER CLIPPING ABOUT 100 MINI PEN NEEDLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741078 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT UP TO 800 TIMES THE BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE IS NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER REPORTED THE BD SAFECLIP STOPPED WORKING AFTER 700 OR 800 TIMES STATED, DOES NOT CLIP NEEDLES ANYMORE AND HE'S USING THE DEVICE WITH A 31G SYRINGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17578788 ↗
• MalfunctionJul 20, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE DEVICE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE BD SAFECLIP IS NOT CLIPPING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367817 ↗
• MalfunctionJul 13, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING USE WITH BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE DEVICE THE DEVICE IS NOT OPERATING CORRECTLY, IT WILL NOT "SPRING BACK" IN READY POSITION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, ONCE HE CLIPS THE NEEDLE, THE DEVICE WILL NOT "SPRING BACK" IN A READY POSITION TO USE AGAIN. STATED, HE HAS TO PUSH IT BACK WITH HIS HAND SO ITS READY TO USE AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322411 ↗
• MalfunctionJul 11, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING USE WITH BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE DEVICE IT WOULD NOT CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEW BD SAFECLIP WILL NOT CLIP STATED, SHE IS USING THE PRODUCT WITH 4MM PEN NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297486 ↗
• MalfunctionJun 29, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ IS NO LONGER CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE NEEDLE CUTTER NO LONGER CUTS ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234413 ↗
• MalfunctionJun 27, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BD SAFE-CLIP¿ WAS JAMMED AND NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, SAFECLIP IS NOT CLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211765 ↗