BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM

    MDR report key: 16250814 · Received January 26, 2023

    Report

    Report Number
    9616656-2023-00030
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 10, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201365
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 22-FEB-2023. H6: INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WITH NO SHIELD ALONG WITH THREE LOOSE TEARDROP LABELS AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2082844, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER ATTACHING A PEN NEEDLE TO THE PEN, THE USER ATTEMPTED INJECTION; HOWEVER, THE DRUG SOLUTION DID NOT COME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER ATTACHING A PEN NEEDLE TO THE PEN, THE USER ATTEMPTED INJECTION; HOWEVER, THE DRUG SOLUTION DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109673 BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN 00382903201365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown