BD Ultra-Fine 328418Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 00382908418034), received between Oct 17, 2017 and Sep 24, 2026 — classified as 8 injuries, 214 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880619 ↗
• MalfunctionSep 24, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880450 ↗
• MalfunctionOct 22, 2025Break; Break

  EMAIL: HELLO ALL, I HOPE THIS EMAIL FINDS YOU WELL. I RECEIVED A MESSAGE FROM OUR CUSTOMER SUPPORT TEAM REGARDING A CUSTOMER COMPLAINT. THIS IS THE INFORMATION I WAS ABLE TO OBTAIN. CUSTOMER NAME: PHONE: CUSTOMER STATES HE HAS BEEN TRYING TO FILE THIS COMPLAINT FOR MORE THAN A YEAR. THE NEEDLES ARE BREAKING OFF IN HIS SKIN AND HE HAS TO REMOVE THEM WITH TWEEZERS. HE SAID THIS HAPPENED A YEAR AGO AND THEN AGAIN MORE RECENTLY ABOUT 2 WEEKS AGO. HE STATES IT IS NOT SPECIFIC TO A PARTICULAR LOT NUMBER. HE ALSO STATES THE NEEDLES BEEN UPON INSERTION. HE STATED HE HAS LEFT MULTIPLE MESSAGES AND HAS EMAILED WITH NO RESPONSE. BASED ON THE INFORMATION RECEIVED FROM CUSTOMER SUPPORT, HE IS THREATENING TO TAKE THIS TO THE MEDIA/INTERNET IF HE DOES NOT SPEAK TO SOMEONE. I DID SPEAK WITH THE CUSTOMER AND HE DID NOT STATE THAT IN MY CONVERSATION WITH HIM. PLEASE CONTACT HIM AT YOUR EARLIEST CONVENIENCE. THANK YOU. (B)(6) 2025. ADDITIONAL INFORMATION. I CALLED CONSUMER TO FOLLOW UP ON COMPLAINT. CONSUMER STATED THAT OVER THE PAST YEAR HE HAD ISSUES WITH SEVERAL SYRINGES. THE MOST RECENT ISSUE IS FROM LOT # 4290049, PRODUCT # 328418. CONSUMER STATED THAT THE NEEDLES BEND DURING INJECTION. PREVIOUS

  Patient problems: Foreign Body In Patient

  MAUDE report 23358472 ↗
• 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: 4349670 CATALOG: 328418 SAMPLES: NO-WILL BE DISCARDING THEM. SEE RELATED CASES, 00023728, 00023730 CL

  Patient problems: Hyperglycemia; No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21915022 ↗
• MalfunctionApr 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  HOW OFTEN HAS THE ISSUE OCCURRED? ONCE WHEN DID THE INCIDENT OCCUR? UNKNOWN DESCRIPTION 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 FROM: CUSTOMER CARE. SENT: MONDAY, (B)(6) 2025 3:40 PM. TO: (B)(6). SUBJECT: FWD: YOU HAVE A REPLY - REQ-(B)(4) - FW: MEDICAL INQUIRY RESPONSE FOR: (B)(4). HELLO TEAM, PLEASE LOOK INTO THE FOLLOWING QUERY AND DO THE NEEDFUL. THANKS, AND REGARDS, (B)(6) ON MON, (B)(6), 2025 4:06 PM, MEDICAL <(B)(6)> 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 SENT: MONDAY, (B)(6) 2025 3:25 PM. TO: MEDICAL INFORMATION <(B)(6)>. SUBJECT: FW: MEDICAL INQUIRY RESPONSE FOR: (B)(4). HI, PLEASE SEE EMAIL BELOW. I WAS DIRECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859100 ↗
• MalfunctionDec 5, 2024Break; Break

  CONSUMER STATED, SHE HAD 3 NEEDLES BREAK OFF INTO HER INJECTIONS SITE ON DIFFERENT DAYS. STATED, SHE WAS ABLE TO REMOVE THE NEEDLES ALL THREE TIMES. STATED, SHE WAS LEFT WITH SOME BRUISING, SWELLING AND SORENESS AS A RESULT OF THE NEEDLE BREAKS STATED, SHE DID NOT SEEK MEDICAL INTERVENTION. ONE BREAK OCCURRED ON OCTOBER 16TH, A SECOND NEEDLE BREAK OCCURRED ON NOVEMBER 10TH AND THE THIRD NEEDLE BREAK IS "UNKNOWN" STATED, SHE STUCK HER FINGER ON A LOOSE NEEDLE IN A PACKAGE OF SYRINGES ON NOVEMBER 9TH. STATED, ISSUES OCCURRED FROM THE SAME BOX AND THE SAME PACKAGE. STATED, SHE WILL EMAIL A PHOTO TO SHOW THE BRUISING ON HER INJECTION SITE LOT: 4144037 CATALOG: 328418 DATE OF EVENT: NOVEMBER 10TH-NEEDLE BREAK OCTOBER 16TH, NEEDLE BREAK, NOVEMBER 9TH, NEEDLE STICK. SAMPLES: YES CL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20858899 ↗
• MalfunctionDec 5, 2024Defective Device; Defective Device

  CONSUMER STATED, SHE HAD 3 NEEDLES BREAK OFF INTO HER INJECTIONS SITE ON DIFFERENT DAYS. STATED, SHE WAS ABLE TO REMOVE THE NEEDLES ALL THREE TIMES. STATED, SHE WAS LEFT WITH SOME BRUISING, SWELLING AND SORENESS AS A RESULT OF THE NEEDLE BREAKS STATED, SHE DID NOT SEEK MEDICAL INTERVENTION ONE BREAK OCCURRED ON OCTOBER 16TH, A SECOND NEEDLE BREAK OCCURRED ON NOVEMBER 10TH AND THE THIRD NEEDLE BREAK IS "UNKNOWN" STATED, SHE STUCK HER FINGER ON A LOOSE NEEDLE IN A PACKAGE OF SYRINGES ON NOVEMBER 9TH. STATED, ISSUES OCCURRED FROM THE SAME BOX AND THE SAME PACKAGE. STATED, SHE WILL EMAIL A PHOTO TO SHOW THE BRUISING ON HER INJECTION SITE. LOT: 4144037. CATALOG: 328418. DATE OF EVENT: NOVEMBER 10TH-NEEDLE BREAK. OCTOBER 16TH, NEEDLE BREAK, NOVEMBER 9TH, NEEDLE STICK. SAMPLES: YES CL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20858575 ↗
• MalfunctionDec 5, 2024Break; Break

  CONSUMER STATED, SHE HAD 3 NEEDLES BREAK OFF INTO HER INJECTIONS SITE ON DIFFERENT DAYS. STATED, SHE WAS ABLE TO REMOVE THE NEEDLES ALL THREE TIMES. STATED, SHE WAS LEFT WITH SOME BRUISING, SWELLING AND SORENESS AS A RESULT OF THE NEEDLE BREAKS STATED, SHE DID NOT SEEK MEDICAL INTERVENTION ONE BREAK OCCURRED ON OCTOBER 16TH, A SECOND NEEDLE BREAK OCCURRED ON NOVEMBER 10TH AND THE THIRD NEEDLE BREAK IS "UNKNOWN" STATED, SHE STUCK HER FINGER ON A LOOSE NEEDLE IN A PACKAGE OF SYRINGES ON NOVEMBER 9TH. STATED, ISSUES OCCURRED FROM THE SAME BOX AND THE SAME PACKAGE. STATED, SHE WILL EMAIL A PHOTO TO SHOW THE BRUISING ON HER INJECTION SITE LOT: 4144037. CATALOG: 328418. DATE OF EVENT: NOVEMBER 10TH-NEEDLE BREAK. OCTOBER 16TH, NEEDLE BREAK, NOVEMBER 9TH, NEEDLE STICK. SAMPLES: YES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20857894 ↗
• MalfunctionDec 5, 2024Break; Break

  CONSUMER STATED, SHE HAD 3 NEEDLES BREAK OFF INTO HER INJECTIONS SITE ON DIFFERENT DAYS. STATED, SHE WAS ABLE TO REMOVE THE NEEDLES ALL THREE TIMES. STATED, SHE WAS LEFT WITH SOME BRUISING, SWELLING AND SORENESS AS A RESULT OF THE NEEDLE BREAKS STATED, SHE DID NOT SEEK MEDICAL INTERVENTION ONE BREAK OCCURRED ON (B)(6), A SECOND NEEDLE BREAK OCCURRED ON (B)(6) AND THE THIRD NEEDLE BREAK IS "UNKNOWN" STATED, SHE STUCK HER FINGER ON A LOOSE NEEDLE IN A PACKAGE OF SYRINGES ON (B)(6). STATED, ISSUES OCCURRED FROM THE SAME BOX AND THE SAME PACKAGE. STATED, SHE WILL EMAIL A PHOTO TO SHOW THE BRUISING ON HER INJECTION SITE LOT: 4144037, CATALOG: 328418, DATE OF EVENT: NOVEMBER 10TH-NEEDLE BREAK, OCTOBER 16TH, NEEDLE BREAK, NOVEMBER 9TH, NEEDLE STICK, SAMPLES: YES, CL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20855480 ↗
• MalfunctionNov 11, 2024Leak/Splash; Leak/Splash

  PLUNGER ROD DIFFICULT TO MOVE. CONSUMER DOES NOT REUSE. LOT #: 4030045. CATALOG #: 328418. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653110 ↗
• MalfunctionNov 6, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED, HE COULD NOT DRAW HIS INSULIN. STATED, HIS NEEDLES SEEMED LONGER THAN NORMAL, (INCORRECT NEEDLE LENGTH). 2 SYRINGES AFFECTED, LOT: 4144037, CATALOG: 328418, DATE OF EVENT: 2024-13-10, SAMPLES: YES, CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622165 ↗
• MalfunctionSep 6, 2024Leak/Splash; Leak/Splash

  CONSUMER LEFT VOICEMAIL REPORTING THAT THE SYRINGE IS DEFECTIVE. I RETURNED CONSUMER'S CALL AND SHE STATED THAT THE PLUNGER ROD SEPARATED FROM THE RUBBER STOPPER. LOT #: 3205989. CATALOG #: 328418. DATE OF EVENT: 08-14-2024. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158072 ↗
• MalfunctionJun 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CONSUMER STATED, NEEDLES ARE "DIFFERENT LENGTHS". STATED, SOME NEEDLE ARE "LONG" AND SOME ARE "SHORT". LOT: UNKNOWN, CATALOG: 328418, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616252 ↗
• MalfunctionJun 17, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED THE NEEDLE BENDS DURING INJECTION. THEN IT CLOGS AND CAN'T GET FULL DOSE. DENIED REUSE OF NEEDLES. DOES NOT PREFILL SYRINGES. DC . CONSUMER REPORTED WHEN REMOVED SHIELD FROM THE NEEDLE ON 1 SYRINGE FROM THIS BOX THE NEEDLE WAS BENT. INFORMED CALLER TO NEVER STRAIGHTEN NEEDLES. SHE DOES THIS. DC . LOT # 5306833. CATALOG# 328418. DATE OF EVENT UNKNOWN . SAMPLE STATUS AWAITING SAMPLES THE 2 FROM ABOVE AND WILL SEND BACK AN UNOPENED BAG. DC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547248 ↗
• MalfunctionApr 26, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED, THE PLUNGER IS DIFFICULT TO PUSH WHEN TAKING INJECTION. STATED, HE BROKE A PLUNGER FROM PUSHING TOO HARD, (THAT ONE WAS DISCARDED BUT IT CAME FROM THE SAME BOX) LOT: 3205989 CATALOG: 328418 DATE OF EVENT: UNKNOWN SAMPLES: YES DECLINED REPLACEMENT CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193117 ↗
• MalfunctionApr 8, 2024Break; Break

  CONSUMER REPORTED WHILE DRAWING FROM HER OZEMBEC VIAL, THE NEEDLE BROKE. DENIED REUSE OF NEEDLES. HAPPENED WITH 2 DIFFERENT SYRINGES TODAY. LOT #: 3219478. CATALOG#: 328418. DATE OF EVENT: 03.13.2024. SAMPLE STATUS: DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061235 ↗
• MalfunctionJan 12, 2024Break; Break

  CONSUMER REPORTED WHEN INJECTING 1 NEEDLE BENT. BENT IT BACK STRAIGHT THEN THE NEEDLE FELL TO THE FLOOR LOT # UNKNOWN WILL NOT KNOW CATALOG# 328418. DATE OF EVENT UNKNOWN - 2 WEEKS AGO SAMPLE STATUS DISCARD. CS0069368 / SF 00018059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501849 ↗
• MalfunctionJan 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  CONSUMER REPORTED THAT THE RUBBER STOPPER IS DAMAGED, HE STATED THAT IT APPEARS TO MELTED IN THE BARREL. CONSUMER ALSO REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE. CONSUMER DOES NOT RE-USE. CONSUMER ONLY SAVED THE SYRINGE WITH THE DAMAGED STOPPER, THE OTHER SYRINGES WERE DISCARDED. LOT #: 3030357. CATALOG #: 328418. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499490 ↗
• MalfunctionDec 25, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE USING THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE STOPPER WAS STUCK INSIDE THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, THE "STOPPER" IS STUCK INSIDE THE BARREL, PREVENTING PLUNGER ROD FROM MOVING TO DRAW INSULIN. STATED, CANNOT USE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390573 ↗
• MalfunctionNov 21, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING SYRINGE FROM THIS BOX WITH A CRYSTAL LIKE SUBSTANCE. NOTICED WHEN PLACING AIR INTO HER VIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188305 ↗
• MalfunctionOct 13, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 328418. BATCH#: 3100616. IT WAS REPORTED BY THE CONSUMER THAT FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. VERBATIM: CONSUMER COMMENTS - PREFILLS SYRINGES 10 AT A TIME. FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. CATALOG# 328418. DATE OF EVENT (B)(6) 2023 = 2 SYRINGES. DATE OF EVENT UNKNOWN = 2 SYRINGES LAST WEEK. SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936572 ↗
• MalfunctionOct 13, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 328418 BATCH#: 3100616 IT WAS REPORTED BY THE CONSUMER THAT FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. VERBATIM: CONSUMER COMMENTS - PREFILLS SYRINGES 10 AT A TIME. FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. CATALOG# 328418 DATE OF EVENT (B)(6) 2023 = 2 SYRINGES DATE OF EVENT UNKNOWN = 2 SYRINGES LAST WEEK SAMPLE STATUS AWAITING SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936571 ↗
• MalfunctionOct 9, 2023Break; Break

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE BROKE OFF IN HER ARM. SHE WAS ABLE TO REMOVE NEEDLE FROM ARM HERSELF. NO MEDICAL ATTENTION NEEDED. CALLER DENIED REUSE OF NEEDLES. LONG TIME DIABETIC. ITEM IN HER SHARP'S CONTAINER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17901660 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED WHILE USING THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE BREAKS OFF. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLES BEND AND SOMETIMES BREAK WHEN TAKING INJECTION. STATED, IF A NEEDLE BREAKS OFF IN HER SKIN, SHE IS ABLE TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873243 ↗
• MalfunctionAug 21, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT SOME OF THE BD ULTRA-FINE¿ INSULIN SYRINGE'S CANNULA'S ARE TOO LONG OR SHORT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLES ARE DIFFERENT LENGTHS. STATED, SOME ARE "SHORT" AND SOME ARE "LONG"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584617 ↗