BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 29GA 12.7MM FRANCE 100BX

    MDR report key: 11422293 · Received March 5, 2021

    Report

    Report Number
    9616656-2021-00222
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 3/24/2021. H.6. INVESTIGATION: NINETY SIX SEALED 29G X 12.7MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9352092, CAT. NO. 320207 ALONG WITH THIRTEEN SEALED AND TEN OPEN 29G X 12.7MM PEN NEEDLE SAMPLES FROM LOT. NO. 9232044, CAT. NO. 320207. VISUAL EXAMINATION WAS CARRIED OUT ON THE NINETY SIX SEALED SAMPLES FROM LOT. NO. 9352092 AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE THIRTEEN SEALED AND TEN OPEN SAMPLES FROM LOT. NO.9232044, NO ISSUES WERE OBSERVED WITH THE SEALED SAMPLES, MISSING SHIELDS AND EMPTY COVERS WERE OBSERVED ON THE OPENED SAMPLES. EVIDENCE OF A TEARDROP LABEL BEING APPLIED WAS OBSERVED ON THE RETURNED SAMPLES. 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 ALL CONFIRMED SAMPLES WERE RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN 29GA 12.7MM FRANCE 100BX EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THEM HAVE NO SEALS AND FOR OTHERS ONLY THE PROTECTIVE CAP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PN 29GA 12.7MM FRANCE 100BX EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THEM HAVE NO SEALS AND FOR OTHERS ONLY THE PROTECTIVE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320899 PN 29GA 12.7MM FRANCE 100BX PEN NEEDLE FMI BECTON DICKINSON AND CO. 9352092

    Patients

    Seq Age Sex Outcome Treatment
    1