BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿¿ ORAL SYRINGE WITH TIP CAP

    MDR report key: 8287380 · Received January 29, 2019

    Report

    Report Number
    1213809-2019-00128
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 15, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED THREE AMBER ORAL 3ML SYRINGES WITH PLUNGER RODS PULLED UP. SAMPLES REPORTED TO BE FROM BATCH #8236737 (B)(4). ALL 3 PLUNGER RODS HAD ONE OF THEIR RIBS CRACKED NEAR THE THUMB REST. THE DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. NO SAMPLES HAVE BEEN RECEIVED FOR THE OTHER 3 BATCHES. A COMPLAINT HISTORY CHECK WAS PERFORMED FOR ALL OF THE BATCHES. NO COMPLAINTS FOR ANY RELATED DEFECTS HAVE BEEN RECEIVED FROM OTHER CUSTOMERS FOR ANY OF THE BATCHES TO DATE. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ ORAL SYRINGE WITH TIP CAP PLUNGER RODS WERE BROKEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8236737. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2018-08-24. MEDICAL DEVICE LOT #: 8263592. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2018-09-20. MEDICAL DEVICE LOT #: 8263594. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2018-09-20. MEDICAL DEVICE LOT #: 8263595. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2018-09-20. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ ORAL SYRINGE WITH TIP CAP PLUNGER RODS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79207 BD¿¿ ORAL SYRINGE WITH TIP CAP LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other