BD Ultra-Fine 328203Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00382903282036), received between Apr 10, 2018 and Sep 24, 2026 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K213478); they may or may not involve this specific model.

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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Off-Label Use

  Pet owner Reported when injecting into her dog on 2 different times with Solostar Lantus insulin feels the insulin did not go into the dog. she could smell the insulin. Discarded the 2 needles in question. sending mail kit for 3-5 unused needles from this box. She informed Solostar. DC Lot # 2228002Catalog# 328203Date of Event unknownSample Status awaiting sampleThis intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken one additional complaint record was created for Difficult/Unable to Operate (not getting dose). With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. Komal Mehta 06 Sep 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880147 ↗
• InjuryJan 5, 2026Break; Patient-Device Incompatibility

  THE CONSUMER REPORTED THE "PATIENT END" OF THE PEN NEEDLE BROKE OFF IN HER STOMACH AFTER INJECTION. STATED, SHE DOES NOT RE-USE PEN NEEDLES. STATED, SHE ROTATES THE DIFFERENT INJECTION SITES. STATED, SHE COULD NOT REMOVE IT HERSELF SO SHE WENT TO THE EMERGENCY ROOM, ((B)(6) 2025) STATED, THE NEEDLE WAS LOCATED AFTER AN X-RAY WAS PERFORMED. STATED, SHE HAD SURGERY TO REMOVE THE NEEDLE ON (B)(6) 2025 BUT THE PROCEDURE WAS UNSUCCESSFUL. STATED, HER DISCHARGE INSTRUCTIONS WERE TO KEEP AN EYE OUT IF ANYTHING CHANGED WITH THE INJECTION SITE. STATED, SHE'S BEEN USING THE PRODUCT FOR OVER 20 YEARS AND NEVER HAD AN ISSUE. LOT: 4269020. CATALOG: 328203. EXPIRATION DATE: 2029-09-30. DATE OF EVENT: 2025-11-07. EMERGENCY ROOM- (B)(6) 2025. SURGERY DATE: (B)(6) 2025. SAMPLE: NO.

  Patient problems: Foreign Body In Patient

  MAUDE report 23959496 ↗
• MalfunctionMay 14, 2025Off-Label Use; Off-Label Use

  PET OWNER REPORTED WHEN INJECTING INTO HER DOG ON 2 DIFFERENT TIMES WITH SOLOSTAR LANTUS INSULIN FEELS THE INSULIN DID NOT GO INTO THE DOG. SHE COULD SMELL THE INSULIN. DISCARDED THE 2 NEEDLES IN QUESTION. SENDING MAIL KIT FOR 3-5 UNUSED NEEDLES FROM THIS BOX. SHE INFORMED SOLOSTAR. DC. LOT#: 2228002, CATALOG#: 328203, DATE OF EVENT: UNKNOWN, SAMPLE STATUS: AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018658 ↗
• MalfunctionApr 25, 2025Break; Break

  CONSUMER IS REPORTING "NEEDLE BREAK" WHEN TAKING INJECTIONS, (THE PATIENT END) STATED, WITH MOST OF THE BOXES HE'S RECEIVED IN THE LAST TWO YEARS, HE HAS EXPERIENCED THE ISSUE, (COULD NOT PROVIDE LOT OR HOW MANY BOXES HAVE BEEN USED FOR THE LAST TWO YEARS). STATED, HE IS ABLE TO REMOVE THE NEEDLES FROM HIS BODY WHEN THEY BREAK OFF. STATED, HE DOES NOT RE-USE AND ROTATES THE DIFFERENT INJECTION SITES, STATED, HE HAS BEEN USING THE PRODUCT FOR OVER 40 YEARS AND NEVER HAD ANY PROBLEMS UNTIL 2 YEARS AGO. THIS IS THE FIRST TIME THE CONSUMER IS CALLING IN TO REPORT THE PROBLEM. STATED, THE QUALITY HAS GONE DOWN WITH THE PRODUCT AND THE NEEDLES ARE TOO THIN. STATED, NO INJURY TO REPORT, LOT: 2123114, CATALOG: 328203, DATE OF EVENT: UNKNOWN, SAMPLES: YES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21914996 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  CONSUMER REPORTED TEAR DROP LABELS MISSING FROM 18 PEN NEEDLES. HE STATED THAT THE LABELS WERE COMPLETELY MISSING FROM THE NEEDLES AND NOT IN THE BOX. LOT#: 3073558, CATALOG#: 328203, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412330 ↗
• MalfunctionNov 22, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING PEN NEEDLES. STATED, HE PRIMES ONE UNIT. LOT: 3318774, CATALOG: 328203, DATE OF EVENT: UNKNOWN, SAMPLES: NO CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759403 ↗
• MalfunctionApr 1, 2024Misconnection; Misconnection

  CONSUMER REPORTED, SHE IS NOT ABLE TO ATTACH THE NON PATIENT END TO HER INSULIN PEN PRIOR TO INJECTION. STATED, SHE IS NOTICING AN "EXTRA PIECE OF PLASTIC" IN THE HUB THAT IS PREVENTING THE NON PATIENT END FROM ATTACHING. LOT: 1258948; CATALOG: 328203; DATE OF EVENT: UNKNOWN; SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015288 ↗
• MalfunctionJan 8, 2024Break; Break

  CONSUMER REPORTED FOUND 2 NEEDLES THAT BROKE AT THE BASE OF THE NEEDLE- WHILE INJECTING. CALLER IS BED BOUND. LOT # 2228002 CATALOG# 328203 DATE OF EVENT 12/11/2023 DISCARD NEEDLE - WENT TO HOSPITAL FOR XRAY. THEY COULD NOT LOCATE THE NEEDLE AT STOMACH INJECTION SITE. DENIED REUSE. DOES NOT PINCH UP SKIN FOR INJECTIONS. HAS AN AIDE THAT ASSISTS WITH INJECTIONS DATE OF EVENT 12/14/2023 AWAITING SAMPLE HAS NOT RECEIVED MEDICAL ATTENTION FOR THIS EVENT AS OF YET. DENIED REUSE - DOES NOT PINCH UP SKIN FOR INJECTIONS. HAS AN AIDE THAT ASSISTS WITH INJECTIONS. CALLER IS A RETIRED HEALTH CARE PROFESSIONAL. DC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472337 ↗
• MalfunctionDec 14, 2023No Flow; No Flow

  CONSUMER REPORTED THAT 2 PEN NEEDLES CLOGGED DURING INJECTION. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END NEEDLES. AND TO COMPLETE A FLOW CHECK WITH ALL INJECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324290 ↗
• MalfunctionNov 20, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO PRIME. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED ON VOICE MESSAGE - USING THE ULTRA FINE ORIGINAL PEN NEEDLES UNABLE TO USE PEN NEEDLE ON (B)(6) 2023. THE NEEDLE IS CLOGGED DURING INJECTION. INJECTS 1X A DAY. DID NOT THINK TO TRY ANOTHER PEN NEEDLE FROM THE BOX. HAS NOT TAKEN INSULIN SINCE SATURDAY (B)(6) 2023. SHE CALLED HER DOCTOR TO INFORM OF THIS THEY HAVE NOT CALLED HER BACK. CONTACTED PHARMACY - PHARMACY SAID TO CALL BD. CALLER HAS THE PEN NEEDLE BOX AT HOME SHE IS CURRENTLY AT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169448 ↗
• MalfunctionAug 14, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES INNER SHIELD WAS STILL ON. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER CALLED IN TO SEE IF SHE WAS USING THE PRODUCT CORRECTLY. ASKED IF "INNER SHIELD" SHOULD BE REMOVED TO ADMINISTER INJECTION. STATED, SHE IS ONLY REMOVING THE "CLEAR OUTTER COVER". STATED, SHE HAS BEEN GIVING HER SPOUSE INJECTIONS FOR A FEW MONTHS WITH "INNER SHIELD" STILL ON.

  Patient problems: Hyperglycemia

  MAUDE report 17547047 ↗
• MalfunctionFeb 17, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM WAS NOT ILLEGIBLE TO READ LOT NUMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN'T SEE THE LOT NUMBER ON PEN NEEDLE TAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397885 ↗
• InjuryFeb 15, 2023Leak/Splash; Inadequate or Insufficient Training; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Inadequate or Insufficient Training; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM EXPERIENCED (SHORT DESCRIPTION OF EVENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED DID NOT REMOVE THE INNER SHIELD BEFORE INJECTION FOR ALL INJECTION IN THIS PAST YEAR. CALLER THOUGHT IT WAS LEAKING.

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

  MAUDE report 16383302 ↗
• MalfunctionJan 23, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PEN WILL NOT PRESS OUT THE INSULIN. ITS CLOGGED. CHANGED THE BD PEN NEEDLE STILL DOES NOT WORK. CHECKED THE NON PATIENT END NEEDLE AND IT STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231044 ↗
• MalfunctionDec 28, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLE EXPERIENCED A PATIENT END CANNULA THAT WAS TOO LONG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER MENTIONED THAT SHE DID NOT LIKE USING THE ORIGINAL PEN NEEDLES BECAUSE THE NEEDLE IS TOO LONG AND THEY HURT WHEN TAKING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064639 ↗
• MalfunctionDec 7, 2022Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED INJECTION SITE IS WET WHEN REMOVED AFTER INJECTION. CALLERS SPOUSE COMPLETES INJECTIONS ON HIM, HOLD INTO SITE FOR 5 SECONDS ONLY AND HAS THUMB ON DOSE BUTTON WHEN INSERTING THE NEEDLE INTO SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929657 ↗
• InjuryOct 19, 2022Break; Break

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM BROKE OFF IN PATIENT ABDOMEN WHEN TAKING INJECTION. SURGERY WAS REQUIRED TO EXTRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE STATED PATIENT END BROKE OFF IN HER HUSBAND ABDOMEN WHEN TAKING INJECTION STATED, SHE TOOK HER HUSBAND TO EMERGENCY ROOM AND XRAYS WERE DONE. STATED, NEEDLE WAS LOCATED IN HER HUSBAND ABDOMEN AND THE EMERGENCY ROOM DOCTOR REFERRED THEM TO A SURGEON. STATED, SURGERY WAS PERFORMED AND NEEDLE WAS REMOVED THE SAME DAY AS NEEDLE BREAK.

  Patient problems: Foreign Body In Patient

  MAUDE report 15635259 ↗
• MalfunctionJun 10, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT SEVERAL NEEDLES CLOG DURING INJECTION WHILE USING THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND BETWEEN 4 TO 10 PEN NEEDLES TO CLOG DURING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651824 ↗
• InjuryApr 22, 2022Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT), AN UNSPECIFIED AMOUNT OF NEEDLES BROKE OFF. THE NEEDLE BROKE OF IN PATIENT. PATIENT WENT TO THE DR. TO HAVE IT REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLES BREAK OFF IN THE INJECTION SITE. CONSUMER STATED THAT HE GOES TO THE DOCTOR TO HAVE THEM REMOVED, STATED THAT THE ISSUE HAS OCCURRED MORE THAN ONCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14187400 ↗
• MalfunctionApr 4, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT 12 BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED 12 MISSING THE PINK INNER SHIELDS. NO INJURY FROM THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996077 ↗
• MalfunctionJan 28, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE DIABETIC NEEDLE IS NOT WORKING PROPERLY AS NO INULIN COMES OUT AND THIS HAS OCCURRED SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385706 ↗
• MalfunctionJan 21, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THE PEN NEEDLE DOES NOT ATTACH OR FIT CORRECTLY. DATE OF EVENT : UNKNOWN; SAMPLES : AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13316657 ↗
• MalfunctionJan 10, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ PEN NEEDLES, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THE PEN DEPRESSES PART OF THE WAY BUT STOPS BEFORE ALL OF THE INULIN IS RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210375 ↗
• MalfunctionNov 12, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLES WAS UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED BD PEN NEEDLES CLOG DURING FLOW CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805169 ↗
• MalfunctionOct 7, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT PEN NDL 29GA 12.7MM 100 BX 1200 USA WAS CLOGGED AND UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER, THE PEN NEEDLE CLOGGED. VERBATIM: CONSUMER REPORTED FINDING THE PEN NEEDLE TO CLOG THE KWIK PEN DURING FLOW CHECK AND INJECTION. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT. SHE CLAIMS TO HAVE SPOKEN WITH SOMEONE IN THE PAST WHO HELPED HER THRU CHANGING THE NEEDLE WITH NEW PEN NEEDLE AND COMPLETED INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213478. One submission often covers many models, so check the product and lot details in each record.

• Z-3180-2026 · Jul 26, 2023 · Open, Classified
  EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100