BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE PLASTIPAK LUER SLIP

    MDR report key: 7723389 · Received July 26, 2018

    Report

    Report Number
    3003152976-2018-00310
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 29, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK LUER SLIP HAD A BROKEN/DAMAGED PLUNGER BEFORE USE. THERE WERE NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1802003, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-02-15. MEDICAL DEVICE LOT #: 1711030, MEDICAL DEVICE EXPIRATION DATE: 2022-10-31, DEVICE MANUFACTURE DATE: 2017-12-04. (B)(\6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE UNUSED SAMPLE WITHOUT PACKAGING WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLE, THE THUMB PRESS OF THE PLUNGER WAS OBSERVED BROKEN. THROUGH MAGNIFIED INSPECTION, NO MOLDING DEFECTS COULD BE IDENTIFIED AS THE CAUSE OF THE BROKEN PLUNGER. A DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT NUMBER 1711030 DID NOT REVEAL ANY ANOMALIES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE BROKEN THUMB PRESS. A DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT NUMBER 1802003 REVEALED ONE ANOMALY DURING PRODUCTION. DURING THE ASSEMBLY PROCESS, A FAILURE WAS FOUND WITHIN THE MACHINES WHICH CAUSED THE PLUNGERS TO GET CAUGHT WITHIN THE ASSEMBLY WHEELS. ONCE THE FAILURE WAS DETECTED, THE DEFECTIVE SAMPLES WERE REJECTED AND THE MECHANICAL TEAM REPAIRED THE FAILURE. THE PLUNGER ROD FOR THIS INCIDENT COULD HAVE BEEN A RESULT OF THIS ASSEMBLY PROCESS FAILURE. AS THE SAMPLE RECEIVED WAS OUTSIDE OF THE BLISTER PACKAGING, THE LOT NUMBER CANNOT BE DETERMINED AND THEREFORE THE ASSEMBLY RELATED FAILURE CANNOT BE CONFIRMED. INVESTIGATION CONCLUSION: SINCE NO MOLDING DEFECT HAS BEEN FOUND IN THE SAMPLE RECEIVED AND IT CANNOT BE CONFIRMED WHICH LOT FROM THE BOTH REPORTED IT BELONGS TO, THE ROOT CAUSE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE PLASTIPAK LUER SLIP HAD A BROKEN/DAMAGED PLUNGER BEFORE USE. THERE WERE NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE PLASTIPAK LUER SLIP HAD A BROKEN/DAMAGED PLUNGER BEFORE USE. THERE WERE NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566963 BD¿ SYRINGE PLASTIPAK LUER SLIP SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other