BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 7529985 · Received May 21, 2018

    Report

    Report Number
    2243072-2018-00288
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 2, 2018
    Report Date
    July 27, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4).THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WERE RETURNED TO SBDM, WITH LOT NUMBER 1802242. RETURNED SAMPLE WAS TESTED FOR LEAKAGE AND RESULTS ARE: WHEN PULLED STRAIGHT, THE SYRINGE SHOW NO LEAKAGE OR AIR ASPIRATION. WHEN PULLED OBLIQUELY, THE SYRINGE SHOW SIGN OF AIR ASPIRATION. DIMENSION MEASUREMENT: FOR THE 1 RETURNED SAMPLE, SBDM MEASURED THE INTERNAL DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER. THE RESULTS SHOWS THE DIMENSION ARE WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORDS FOR LOT 1802242, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL COMPLAINT RECORD FOR SAME SKU, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATIONS, SBDM CONSIDERED THE LIKELY CAUSE FOR THE LEAKAGE TO BE INJECTION WORKING CONDITION. SBDM INVESTIGATED THAT THE MEDICINE HOLDING LINE BETWEEN STOPPER AND BARREL OF 20ML SYRINGE IS REDUCED WHEN THE PLUNGER IS PULLED OBLIQUELY, EVEN AS BOTH STOPPER OUTER DIAMETER AND BARREL INNER DIAMETER ARE WITHIN SPECIFICATION. THIS IS DUE TO THE INTERFERENCE FIT BETWEEN STOPPER AND BARREL OF 20ML SYRINGE IS LESSER THAN OTHER SIZE SYRINGES. THE INTERFERENCE FIT OF 10ML(F1), 30ML(F1.1), 50ML(F1) SYRINGE IS MORE THAN F1.0 BUT THE INTERFERENCE FIT OF 20ML SYRINGE IS F0.95). THIS MAY BE ATTRIBUTE TO MOLDED STOPPER COMPONENT MORE SENSITIVE TO CHANGING OF INJECTION WORKING PARAMETERS, AND IT WILL AFFECT THE INTERFERENCE FIT OF THE STOPPER AND BARREL. THE IDEAL STATE WOULD BE TO ACHIEVE A HIGH MEDICINE HOLDING STRENGTH, IN WHICH THE OUTER DIAMETER OF STOPPER IS BIGGER THAN INNER DIAMETER OF BARREL (MAXIMUM TOLERANCE ALLOWANCE BASED ON SPECIFICATION). CORRECTIVE ACTIONS 1. SBDM HAD QUALITY TRAINING ON THE CUSTOMER COMPLAINT FOR STOPPER INSPECTION WORKERS AND QUALITY CONTROL WORKER. 2. SBDM STRENGTH INSPECTION FOR 20ML STOPPER AND MONITOR THE LEAKAGE OF THE 20ML SYRINGE FOR EVERY LOT NO. BY STRENGTHENING INSPECTION METHOD. 3. SBDM ARE CHECKING AND RECONFIRMING OF INJECTION WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR GASKET MOLD. 4. SBDM MANUFACTURED TEST SAMPLES OF 20ML SYRINGE (36,000EA) AND GET CONFIRMATION THAT THERE WAS NO ISSUE FROM BD (B)(4). SBDM HAS IN HOUSE CAPA-(B)(4) IN PLACE TO MONITOR DEFECT AND ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE WAS FOUND WITH LEAKING AS THE "PLUNGER IS VERY LOOSE. SO THAT DRUG FLUID WAS LEAKED BACK TO PLUNGER". THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE WAS FOUND WITH LEAKING AS THE "PLUNGER IS VERY LOOSE. SO THAT DRUG FLUID WAS LEAKED BACK TO PLUNGER." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371433 BD¿ SYRINGE SYRINGE FMF BECTON DICKINSON 1802242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other