BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5

    MDR report key: 9474978 · Received December 16, 2019

    Report

    Report Number
    9614033-2019-00290
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 29, 2019
    Report Date
    February 5, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. 18 WITH OPENED PACKAGE, 1 WITHOUT PACKAGE, AND 1 PIECE BELONGING TO SAVINGS PHARMACIES ARE RECEIVED BY THE CLIENT, ADDITIONALLY 15 PIECES OF NEEDLE WITHOUT SYRINGE ARE RECEIVED, WHICH WERE SENT TO THE QUALITY CONTROL LABORATORY FOR VISUAL EVALUATION. SAMPLES WERE EVALUATED FOR EPOXY STAINS, AND SURFACE OF THE CANNULA FOR ANY NOTCHES, BURRS, FRACTURES, SCRATCHES, OR CORROSION PRESENCE. DURING THE TESTS PERFORMED, THERE ARE NO CHARACTERISTICS SIMILAR TO THOSE REPORTED BY THE CLIENT DETECTED. DURING THE DOCUMENTARY REVIEW, NO ATTRIBUTABLE PROBLEM WAS FOUND FOR THE DEFECT REPORTED, IN ADDITION, THE SAMPLES PROVIDED BY THE CLIENT PRESENTED COMPLIANT RESULTS IN THE TESTS PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 5ML LL 22GA 1-1/4IN PTK 5 HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: BASICALLY I OBSERVE THAT IN THE ¿UNION¿ OF THE NEEDLE AND THE PLASTIC IT HAS A KIND OF ¿WHITE SILICONE¿ THAT STANDS OUT AND HURTS THE PATIENT. THE DEFECT WAS NOTICED DURING, BEFORE AND AFTER THE USE. THE CUSTOMER RELATE A INJURY DUE TO THE PUNCTURE. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 5ML LL 22GA 1-1/4IN PTK 5 HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: BASICALLY I OBSERVE THAT IN THE ¿UNION¿ OF THE NEEDLE AND THE PLASTIC IT HAS A KIND OF ¿WHITE SILICONE¿ THAT STANDS OUT AND HURTS THE PATIENT. THE DEFECT WAS NOTICED DURING, BEFORE AND AFTER THE USE. THE CUSTOMER RELATE A INJURY DUE TO THE PUNCTURE. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271981 BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5 SYRINGE FMF BECTON DICKINSON DE MEXICO 9015861

    Patients

    Seq Age Sex Outcome Treatment
    1 Other