BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

    MDR report key: 8777674 · Received July 10, 2019

    Report

    Report Number
    1920898-2019-00641
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 25, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055402
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A PHOTO OF A LOOSE 1CC BD ALLERGY SYRINGE. CUSTOMER STATES THAT THE PLUNGER RODS ARE BREAKING. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED A BROKEN PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8266756 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. VISUAL EVALUATION OF THE PICTURE SHOWED A 1.0ML SYRINGE. THE SYRINGE WAS MISSING THE THUMB PRESS. THE PLUNGER, JUST BELOW WHERE THE THUMB PRESS SHOULD BE, WAS FLATTENED, AND NOT ROUND. THE REST OF THE SYRINGE WAS UNDAMAGED AND INTACT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1ML SYRINGE COMPONENTS (BARREL STOPPER, PLUNGER) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DEVICE, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL, ONE SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTION AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES RELATING TO THIS DEFECT DURING THE PRODUCTION OF THIS BATCH. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB WAS FOUND WITH A BROKEN PLUNGER ROD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE PLUNGER RODS ARE BREAKING. PER EMAIL: ON JUNE 20, 2019 COMPANY RECEIVED A DEVICE COMPLAINT INVOLVING BD 1CC 27G X 1/2 SYRINGE (ITEM# BD5540 LOT# 8266756). THE CUSTOMER STATED THAT THE PLUNGERS BREAK FREQUENTLY AND SYRINGES LOOK LIKE THE ATTACHED PHOTO.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K980580 / K941657. 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 WAS REPORTED THAT ONE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB WAS FOUND WITH A BROKEN PLUNGER ROD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE PLUNGER RODS ARE BREAKING. PER EMAIL: ON JUNE 20, 2019 COMPANY RECEIVED A DEVICE COMPLAINT INVOLVING BD 1CC 27G X 1/2 SYRINGE (ITEM# BD5540, LOT# 8266756). THE CUSTOMER STATED THAT THE PLUNGERS BREAK FREQUENTLY AND SYRINGES LOOK LIKE THE ATTACHED PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572395 BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8266756 30382903055402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other