BD Pen Needle 23G x 7mm 4736989Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382904736989), received between Apr 26, 2018 and Jan 18, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT 1 BD PEN NEEDLE 23G X 7MM HAD PRODUCT DAMAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE REPORTED PACKAGE DEFECT WHERE THE FILM OF THE PROTECTIVE SEAL ON THE NEEDLE IS STILL ATTACHED AND THE PLASTIC PART INSIDE IS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285768 ↗
• MalfunctionNov 11, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED BD PEN NEEDLE HAD DAMAGED UNIT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER OPENED THE BOX TO GET THE NEEDLE OUT, BUT HE COULDN'T GET IT OUT BECAUSE THERE WAS A THIN FILM OF SOME KIND STUCK TO THE BACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799462 ↗
• MalfunctionAug 31, 2021Misconnection; Misconnection

  IT WAS REPORTED THAT 1 BD 23G ETW X 7MM PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE COULD NOT BE INJECTED PROPERLY EVEN THOUGH IT WAS INJECTED BY THE HOSPITAL STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393477 ↗
• MalfunctionJan 4, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE US NEEDLE WAS SHORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BDP: LOW FILL VOLUME-PEN DILUENT & OTHERS (SHORT NEEDLE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11115039 ↗
• MalfunctionApr 29, 2020Failure to Deliver; Defective Device; Failure to Deliver; Defective Device

  IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE US HAD AN INJECTION FORCE FAILURE. THIS OCCURRED ON 7 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RECORD IS BEING RAISED FOR NOTIFICATION TO UNDERSTAND THE SUPPLIER CONTROLS SURROUNDING NEEDLE ID TESTING. THE BATCHES REFERENCED IN THIS RECORD PASSED INCOMING INSPECTION AND WERE RELEASED FOR USE IN COMMERCIAL PRODUCTION. INJECTION FORCE (IF) FAILURE DURING FINISHED DEVICE RELEASE TESTING RESULTED IN PT&D TO EXAMINE THE NEEDLE ID WITH A PIN GAUGE (DIAMETER .04597 ± 0.005 MM). THE PIN GAUGE ONLY CHECKS THAT THE ID IS LARGER THAN THE PIN GAUGE BUT DOES NOT PROVIDE VARIABLE DATA. IT WAS THEN DECIDED TO SEND A SMALL SAMPLE SIZE OF NEEDLES OUT FOR MEASUREMENT VIA CT SCANNING. THE DCP NEEDLE CANNULA ID IS SPECIFIED ON THE NEEDLE SPECIFICATION AT 0.0190¿ ¿ 0.0205¿ AND IS DEFINED AS A DEFECT ON THE BD CUSTOMER SPECIFICATION. 8 DCP NEEDLES USED DURING RELEASE IF TESTING WERE SENT FOR CANNULA ID MEASUREMENTS VIA CT SCANNING. 11 MEASUREMENTS WERE TAKEN PER NEEDLE. OF THE 88 MEASUREMENTS TAKEN, ALL 88 WERE FOUND BELOW THE MINIMUM DESIGN TOLERANCE (MIN ¿ 0.0190¿ = 0.483 MM).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010190 ↗
• MalfunctionMar 6, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE 23G ETW X 7MM PEN NEEDLE EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE (SHELF CARTON OR CASE)/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE DEFECT(SEALING DEFECT). THE SEAL ON THE SYRINGE SIDE OF THE NEEDLE WAS SEPARATED INTO 2 SHEETS, AND IT WAS IMPOSSIBLE TO USE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800318 ↗
• MalfunctionDec 12, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE US NEEDLE CONTAINER LID WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTRACTOR PERFORMS VISUAL INSPECTION OF ALL NEEDLES DELIVERED FROM BD. FOR CLARITY VISUAL INSPECTION IS NON-DESTRUCTIVE CHECK OF THE EXTERNAL APPEARANCE OF THE BD NEEDLE CONTAINER. DURING THE INSPECTION OF LOT, ONE NEEDLE CONTAINER LID WAS NOTED TO BE PUNCTURED BY SOME PIECE OF METAL, LIKELY THE NEEDLE ITSELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9456086 ↗
• MalfunctionAug 28, 2019Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  IT WAS REPORTED THAT THE 23G ETW X 7MM PEN NEEDLE US EXPERIENCED DIFFICULTY OPERATING OR NOT WORKING/FUNCTIONING, AND AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DULL NEEDLE& DIFFICULT TO PUSH THE INJECTION BUTTON THE PATIENT'S FAMILY ADMINISTERED THE PEN TO PATIENT. THE PATIENT'S FAMILY CLAIMED THAT THE NEEDLE GOT HALF WAY INTO THE SKIN, BUT IT DIDN'T GET COMPLETELY, AND ALSO HE/SHE ADMINISTRATION FOR PATIENT WAS FINISHED, BUT MEDICAL REPRESENTATIVE CHECKED THE SAMPLE, INJECTION BUTTON WAS NOT INJECTED COMPLETELY. SO IT IS PRESUMED THAT THE ADMINISTRATION IS NOT COMPLETE. THE DOCTOR SAID THAT THERE MIGHT HAVE BEEN A LUMP IN THE ADMINISTRATION SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8940672 ↗
• MalfunctionJun 6, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING USE OF THE PEN NDL 32G 4MM HP 100 BOX FR THE NEEDLE WAS CLOGGED AND THE INJECTION COULD NOT BE MADE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: NEEDLE CLOG. INJECTION COULD NOT BE MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675536 ↗
• MalfunctionJun 3, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING USE OF THE PEN NDL 32G 4MM HP 100 BOX FR A LARGE QUANTITY OF THE NEEDLES WERE DEFECTIVE "CLOGGED." FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: COMPLAINT ABOUT A BOX OF 100 BD NEEDLES 4MM ((B)(4).) REF: 320562 LOT: 8186912 EXP: 31 07 2023. A PATIENT MADE US A REPORT BY BRINGING BACK THE EMPTY BOX, STATING THAT A LARGE QUANTITY OF NEEDLES WERE DEFECTIVE. UPDATE DUE TO MAIL RECEIVED ON MAY 14: NEEDLE CLOG.

  Patient problems: No Information

  MAUDE report 8662826 ↗
• MalfunctionMay 17, 2019Delivered as Unsterile Product; Device Markings/Labelling Problem; Packaging Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem; Packaging Problem

  IT WAS REPORTED THAT BEFORE USE OF THE BD 23G ETW X 7MM PEN NEEDLE¿ US THERE WAS A 100% INSPECTION OF FIVE BATCHES OF THE NEEDLES. THE FOLLOWING DEFECTS WERE FOUND IN THE INSPECTION. DAMAGED OR OPEN UNIT PACKAGE / SEAL WHERE STERILITY IS COMPROMISED (TEAR DROP LABEL); NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE; STERILITY (PRODUCT NOT STERILE). THERE WERE 10 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRITICAL DEFECTS WERE IDENTIFIED DURING 100% INSPECTION OF FIVE BATCHES OF BYDUREON DCP NEEDLES PRODUCT POST IMPLEMENTATION OF SUPPLIER CORRECTIVE ACTIONS. THE CRITICAL DEFECTS IDENTIFIED RESULTED IN COMPROMISED STERILITY. ALL DEFECTS HAVE BEEN SEGREGATED FROM THE BATCHES PER SPECIAL INSTRUCTIONS. ITEM: NDL DC 23G 7MM EQW ETW US AZ ITEM NUMBER 7002401. AZ SPECIFICATION: SPEC-899/SPEC-890. SUPPLIER: BECTON DICKINSON SUPPLIER ITEM CODE (B)(4).. AZ BATCH NUMBER: 294340. SUPPLIER LOT: 7195609 (MANUFACTURED NOVEMBER 2017). PURCHASE ORDER NUMBER: (B)(4). DURING 100% INSPECTION OF THE BATCH OF 387,800 EA, 1 CRITICAL DEFECT WAS IDENTIFIED FOR MISSING, DAMAGED OR DEFECTIVE LABEL AFFECTING STERILITY. ONE NEEDLE IS NOT SEALED. AZ BATCH NUMBER: 294341. SUPP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8620758 ↗
• MalfunctionApr 2, 2019Unsealed Device Packaging

  IT WAS REPORTED THERE WAS A SEALING DEFECT WITH A BD 23G ETW X 7MM PEN NEEDLE¿ US. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT FOUND SEALING DEFECT WHEN HE/SHE OPENED THE PACKAGE. TO BE SPECIFIC, THE WHITE PART OF THE SEALING WAS PEELED AND THE CLEAR PART REMAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476308 ↗
• MalfunctionJul 2, 2018Unsealed Device Packaging

  IT WAS REPORTED THAT THE SEAL WAS FOUND OPEN ON A BD¿ PEN NEEDLE STERILE SINGLE USE BREACHING STERILITY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654986 ↗
• MalfunctionMay 22, 2018Defective Component; Component Missing

  IT WAS REPORTED THAT PACKAGES OF BD¿ PEN NEEDLE STERILE SINGLE USE WERE FOUND WITH DEFECTIVE COVERING, MISSING OR PUNCTURED/TORE BREACHING THE STERILE BARRIER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7532210 ↗
• MalfunctionApr 26, 2018Torn Material

  IT WAS REPORTED THAT THE DROP LABEL WAS FOUND DAMAGED "PUNCTURED, SLIT, TORE" AFFECTING STERILITY ON A BD¿ PEN NEEDLE STERILE SINGLE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465489 ↗