BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD¿ SYRINGE WITH NEEDLE

    MDR report key: 7570709 · Received June 5, 2018

    Report

    Report Number
    2243072-2018-00347
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    April 26, 2018
    Report Date
    September 13, 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 · 0

    INVESTIGATION SUMMARY: 16 SAMPLES WERE RETURNED TO SBDM, THE COMPLAINT LOT NUMBER IS 1802232. RETURNED SAMPLES WERE TESTED FOR LEAKAGE: SBDM CONDUCTED LEAKAGE TEST USING 5 PCS RETURNED SAMPLES AND RESULTS ARE: SYRINGE LEAK TEST: WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. WHEN PULLED OBLIQUELY, 1 OF THE SYRINGES SHOW SIGN OF AIR ASPIRATION. NEEDLE LEAK TEST: WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. HOWEVER, AIR ASPIRATION OR LEAKAGE CAN OCCUR DUE TO PULLING DIRECTION OF PLUNGER AS BELOW AS DEMONSTRATED BY SBDM: USER PULLS PLUNGER IN A STRAIGHT MANNER, NO AIR ASPIRATION OR LEAKAGE CAN BE OBSERVED USER PULLS PLUNGER IN OBLIQUELY DIRECTION, AIR ASPIRATION AND LEAKAGE CAN BE OBSERVED DIMENSION MEASUREMENT: FOR THE 5 PCS RETENTION SAMPLES, 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 1802232. NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL COMPLAINT RECORD FOR SAME SKU, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. CORRECTIVE ACTIONS SBDM HAD QUALITY TRAINING ON THE CUSTOMER COMPLAINT FOR STOPPER INSPECTION WORKERS AND QUALITY CONTROL WORKER. SBDM STRENGTH INSPECTION FOR 20ML STOPPER AND MONITOR THE LEAKAGE OF THE 20ML SYRINGE FOR EVERY LOT NO. BY STRENGTHENING INSPECTION METHOD. SBDM ARE CHECKING AND RECONFIRMING OF INJECTION WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR GASKET MOLD. SBDM MANUFACTURED TEST SAMPLES OF 20ML SYRINGE (36,000EA), AND GET CONFIRMATION THAT THERE WAS NO ISSUE FROM BD KOREA (BD KOREA HAD SENT THE TEST SAMPLES TO VARIOUS CUSTOMERS FOR EVALUATION). CONCLUSION: FROM INVESTIGATIONS, SBDM CONSIDERED THE LIKELY CAUSE 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). SBDM HAS A CAPA (B)(A) IN PLACE TO MONITOR THE DEFECT AND CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELD: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE BETWEEN THE BARREL AND THE PLUNGER OF A 20 ML BD¿ SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE BETWEEN THE BARREL AND THE PLUNGER OF A 20 ML BD¿ SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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 THERE WAS LEAKAGE BETWEEN THE BARREL AND THE PLUNGER OF A 20 ML BD¿ SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410379 20 ML BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON 1802232

    Patients

    Seq Age Sex Outcome Treatment
    1 Other