BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 100 BX 1200 CA

    MDR report key: 10906596 · Received November 25, 2020

    Report

    Report Number
    9616656-2020-01190
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 3, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT PEN NDL 32GA 4MM 100 BX 1200 CA HAD NO INSULIN FLOW DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144 BATCH NO. 0084066, 0049366 IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING PRIMING. ADDITIONAL ISSUES (NPE CANNULA BENT AND NPE CANNULA BROKEN) WERE OBSERVED ON THE SAMPLES RETURNED BY THE CUSTOMER. D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2020-12-10. F.10. DEVICE CODES: 1069. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.6. FDA DEVICE PROBLEM CODE: 1069.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (23) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. ALL 23 RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 14 HAD BENT NON-PATIENT END (NPE) CANNULAS 8 HAD BROKEN NPE CANNULAS (THIS ISSUE WAS INVESTIGATED IN CHILD RECORD 2252686) 1 HAD A STRAIGHT NPE CANNULA; THIS SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR AND WAS ABLE TO EXPEL PROPERLY NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE CANNULA, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED, AS REPORTED. THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT) THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32GA 4MM 100 BX 1200 CA HAD NO INSULIN FLOW DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144 BATCH NO. 0084066, 0049366 IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING PRIMING. ADDITIONAL ISSUES (NPE CANNULA BENT AND NPE CANNULA BROKEN) WERE OBSERVED ON THE SAMPLES RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32GA 4MM 100 BX 1200 CA HAD NO INSULIN FLOW DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144 BATCH NO. 0084066, 0049366 IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING PRIMING. ADDITIONAL ISSUES (NPE CANNULA BENT AND NPE CANNULA BROKEN) WERE OBSERVED ON THE SAMPLES RETURNED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0084066 MEDICAL DEVICE EXPIRATION DATE: 2025-03-31 DEVICE MANUFACTURE DATE: 2020-03-24 MEDICAL DEVICE LOT #: 0049366 MEDICAL DEVICE EXPIRATION DATE: 2025-02-28 DEVICE MANUFACTURE DATE: 2020-02-18 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 32GA 4MM 100 BX 1200 CA HAD NO INSULIN FLOW DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144, BATCH NO. 0084066, 004936. IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372099 PEN NDL 32GA 4MM 100 BX 1200 CA PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1