BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 11098222 · Received December 30, 2020

    Report

    Report Number
    9616656-2020-01306
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    November 25, 2020
    Report Date
    March 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/18/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (11) 8MM, 31G PEN NEEDLES (1 OPEN WITHOUT THE TEAR DROP LABEL OR INNER SHIELD, 10 SEALED) WITH THE SHELF CARTON FROM LOT # 0028858. CUSTOMER STATES THAT THE NEEDLE BROKE OFF IN THE CONSUMER DURING THE INJECTION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED ON ANY OF THE SEALED SAMPLES. HOWEVER, THE OPEN SAMPLE EXHIBITED A BROKEN PATIENT END OF THE CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED EPOXY AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE IS USER RELATED. THE PATIENT END OF THE CANNULA LIKELY BROKE OFF DURING USE OF THE PRODUCT BY THE CUSTOMER THROUGH BENDING/RESTRAIGHTENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 31GA 8MM 100 BX 1200 USA CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320109 BATCH, NO: 0028858. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE CONSUMER DURING THE INJECTION. CONSUMER DID SEEK MEDICAL ATTENTION TO HAVE THE NEEDLE REMOVED. VERBATIM: FROM PHONE CALL ON (B)(6)B2020 12:22:21: CALLED CONSUMER TO FOLLOW UP AND TO OBTAIN ADDITIONAL INFORMATION REGARDING COMPLAINT. CONSUMER STATED THAT HE HAD THE NEEDLE REMOVED AT THE DOCTOR'S OFFICE YESTERDAY, (B)(6) 12. THE NEEDLE WAS DISCARDED BUT HE SAVED THE HUB AND WILL BE SENDING IT IN. CONSUMER ALSO STATED THAT HE MAY BE LOOKING FOR REIMBURSEMENT OF CHARGES THAT INCURRED. CONSUMER DID NOT HAVE THE PRODUCT # AVAILABLE, SAID HE WILL CALL US BACK WITH THE INFORMATION. EMAIL: GREETINGS. I USE BD ULTRA-FINE SHORT PEN NEEDLES, 8 MM X 31G. THE LOT NUMBER INVOLVED IS 0028858 EXP. 2025-01-31. I HAD A PROBLEM IN THAT ONE OF THESE NEEDLES BROKE OFF INTERNALLY DURING INJECTION OF LEVEMIR. A VISIT TO THE HOSPITAL EMERGENCY ROOM WAS UNABLE TO RECOVER THE NEEDLE FRAGMENT. I WAS REFERRED TO A SURGEON WHERE AN OFFICE PROCEDURE WAS ABLE TO RECOVER THE NEEDLE FRAGMENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 31GA 8MM 100 BX 1200 USA CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320109, BATCH NO: 0028858. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE CONSUMER DURING THE INJECTION. CONSUMER DID SEEK MEDICAL ATTENTION TO HAVE THE NEEDLE REMOVED. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 12:22:21: CALLED CONSUMER TO FOLLOW UP AND TO OBTAIN ADDITIONAL INFORMATION REGARDING COMPLAINT. CONSUMER STATED THAT HE HAD THE NEEDLE REMOVED AT THE DOCTOR'S OFFICE YESTERDAY, (B)(6) 2020. THE NEEDLE WAS DISCARDED BUT HE SAVED THE HUB AND WILL BE SENDING IT IN. CONSUMER ALSO STATED THAT HE MAY BE LOOKING FOR REIMBURSEMENT OF CHARGES THAT INCURRED. CONSUMER DID NOT HAVE THE PRODUCT # AVAILABLE, SAID HE WILL CALL US BACK WITH THE INFORMATION. EMAIL: GREETINGS. I USE BD ULTRA-FINE SHORT PEN NEEDLES, 8 MM X 31G. THE LOT NUMBER INVOLVED IS 0028858 EXP. 2025-01-31. I HAD A PROBLEM IN THAT ONE OF THESE NEEDLES BROKE OFF INTERNALLY DURING INJECTION OF LEVEMIR. A VISIT TO THE HOSPITAL EMERGENCY ROOM WAS UNABLE TO RECOVER THE NEEDLE FRAGMENT. I WAS REFERRED TO A SURGEON WHERE AN OFFICE PROCEDURE WAS ABLE TO RECOVER THE NEEDLE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563222 PEN NDL 31GA 8MM 100 BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 0028858 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention