BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP TIP SYRINGE

    MDR report key: 7139028 · Received December 21, 2017

    Report

    Report Number
    1213809-2017-00376
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 1, 2017
    Report Date
    February 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903044165
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DHR REVIEW FOR BATCH 7002731 (P/N 304416): MANUFACTURING DATES: 02/01/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7002731 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. (B)(4) LOOSE 5ML ASSEMBLED SYRINGES WERE RECEIVED BY BD (B)(4) AND REPORTED TO BE FROM BATCH # 7002731. THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE ALL FOUND TO HAVE BROKEN PLUNGER ROD RIB. THE AFFECTED AREA WAS APPROXIMATELY L2/3 THE LENGTH OF THE PLUNGER ROD RIB. SOME SAMPLES HAD A LARGER AFFECTED AREA THAN OTHERS. IN ALL OF THE SAMPLES ONLY ONE PLUNGER ROD RIB WAS AFFECTED. IN (B)(4) OF THE SAMPLES THE RIB REMAINED ATTACHED WHILE IN 13 OF THE SAMPLES, THE BROKEN PORTION OF THE RIB WAS DETACHED. PROBABLE ROOT CAUSE: THE DAMAGE OBSERVED IS LIKELY A RESULT OF A COMPONENT JAM IN THE ASSEMBLY MACHINE. ONCE A PART IS CAUGHT OUTSIDE ITS PATH, EACH PASSING PLUNGER ROD IS THEN POTENTIALLY DAMAGED BY THE JAMMED COMPONENT. ONE OF THE COMMON CAUSES OF JAMS IS A MISALIGNMENT OF THE COMPONENT GUIDE. INVESTIGATION REVEALED THAT THIS ASSEMBLY MACHINE DOES NOT HAVE AN ALIGNMENT PIECE THAT IS PRESENT ON OTHER MACHINES THAT HELPS TO REDUCE THE OCCURRENCE OF JAMS BY ENSURING CONSTANT GUIDE ALIGNMENT. PREVENTIVE ACTIONS: ALIGNMENT PIECE WILL BE INSTALLED AT THE PLUNGER ROD GUIDES TO ENSURE ALIGNMENT DURING ASSEMBLY ON THIS MACHINE. COMPLAINTS WILL BE TRACKED AND TENDED FOR THIS DEFECT ON THIS MANUFACTURING LINE FOLLOWING IMPLEMENTATION. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 PLUNGERS ON BD¿ SLIP TIP SYRINGE(S) WERE BROKEN PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920405 BD¿ SLIP TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7002731 50382903044165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other