BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE

    MDR report key: 7621813 · Received June 20, 2018

    Report

    Report Number
    9616656-2018-00124
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MEDICAL DEVICE CATALOG NUMBER: 320136. MEDICAL DEVICE LOT NUMBER: 7143586. MEDICAL DEVICE EXPIRATION DATE: 05/31/2022. DEVICE MANUFACTURE DATE: 06/30/2017. INVESTIGATION SUMMARY: ONE SEALED 31G X 5MM PEN NEEDLE POLYBAG AND FIVE PHOTOS WERE RETURNED FROM LOT. NO. 7143586, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT AND IT WAS OBSERVED THAT TWO 32G X 4MM PEN NEEDLE SAMPLES FROM CAT. NO. 320136 LOT. NO. 7143601 WERE MIXED IN A 31G X 5MM PEN NEEDLE POLYBAG FROM LOT. NO. 7143586. VISUAL EXAMINATION WAS CARRIED OUT AND IT WAS OBSERVED THAT TWO 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 7143601 WERE MIXED IN A 31G X 5MM PEN NEEDLE POLYBAG FROM LOT. NO. 7143586. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. LOT. NO. 7143586 WAS MANUFACTURED ON LINE 12, JUNE 25TH TO 29TH, 2017 AND PACKAGED ON LINE 667 JULY 3RD TO 5TH, 2017. LOT. NO. 7143601 WAS MANUFACTURED ON LINE 17 JUNE 30TH TO JULY 02ND 2017 AND PACKAGED ON LINE 667 JULY 5TH TO 8TH, 2017. FOLLOWING A REVIEW OF THE ASSEMBLY PACKAGING SEQUENCE IT WAS IDENTIFIED THAT BOTH LOTS WERE STAGED SIDE BY SIDE OUTSIDE THE JAPAN PACKAGING AREA AT THE SAME TIME. THE MOST LIKELY CAUSE IS THAT TWO PEN NEEDLES FROM LOT. NO. 7143586 WERE TRANSFERRED TO LOT. NO. 7143601 DURING THE MOVEMENT OF LOTS TO THE STAGING AREA. LOTS ARE NO LONGER STAGED IN CLOSE CONTACT WITH EACH OTHER THEREFORE NO FURTHER CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE HAD A LABELING ERROR AS "2EA MFP32G4MM GOT MIXED IN THE POLYBAG." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE A BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE HAD A LABELING ERROR AS "2EA MFP32G4MM GOT MIXED IN THE POLYBAG." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466072 BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7143586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other