BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 7653025 · Received June 29, 2018

    Report

    Report Number
    2243072-2018-00434
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 12, 2018
    Report Date
    September 20, 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: FOUR SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1802242. 2 OF THE SAMPLES WERE IN SEALED CONDITION. COMPLAINTS FOR THIS PIR WAS 1. THE TIP OF 20ML SYRINGE WAS EASILY BROKEN. 2. BECAUSE THE GASKET WAS VERY SOFT, DRUG FLUID WAS LEAKED BACKWARD. SBDM CONDUCTED VISUAL INSPECTION ON THE RETURNED SAMPLES, THE TIPS OF THE SYRINGES WERE BROKEN. HOUSE SAMPLES INSPECTION: SBDM INSPECTED 25 PCS HOUSE SAMPLES FROM LOT 1802242, NO ABNORMALITY WAS OBSERVED. LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 2 SEALED SAMPLES RETURNED. SYRINGE LEAK TEST: WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. WHEN PULLED OBLIQUELY, THE SYRINGES SHOW NO LEAKAGE OR 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 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 2 PC COMPLAINT SAMPLE, SBDM MEASURED THE INTERNAL DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER. THE RESULTS SHOWS THE DIMENSION ARE WITHIN SPECIFICATIONS. BARREL INTERNAL DIAMETER: SPEC F20.05 +/- 0.05MM. SAMPLES WERE MEASURED AT F20.016, F20.080. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.039, F21.004. 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 LEAKAGE ISSUES FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATION, ROOT CAUSE POINT OUT TO: BROKEN TIP - SBDM CHECK SYRINGE ASSEMBLY PROCESS, IT IS ASSUMED THE BROKEN TIP IN THE SYRINGE OCCURRED WHILE THE BARREL WAS SET INTO POSITION FOR PRINTING PROCESS IN THE ASSEMBLY MACHINE INDEX. WHILE THE BARREL WAS BEING SET INTO POSITION FOR PRINTING PROCESS, THE METAL INDEX HAD CONTACTED HARD WITH THE BARREL. THIS CAUSES DAMAGE AND SUBSEQUENTLY BROKE THE TIP OF THE SYRINGE. HOWEVER, THE CONTACT BY THE METAL INDEX WAS NOT STRONG ENOUGH TO FULLY BREAK OFF THE TIP, AND THE INSPECTOR COULDN`T FIND VISUALLY CAPTURED THIS BROKEN TIP. LEAKAGE - 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(F1.35), 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: SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. SBDM HAD QUALITY TRAINING ON THE CUSTOMER COMPLAINT FOR STOPPER INSPECTION WORKERS AND QUALITY CONTROL WORKER. SBDM IMPLEMENT TIGHTENED PRODUCT & PROCESS INSPECTION AND STRENGTHENING QUALITY INSPECTION FOR SYRINGE MANUFACTURING PROCESS. SBDM MAINTAINED THE INDEX OF SYRINGE ASSEMBLY MACHINE AND INSTALL WING NOT TO CONTACT BETWEEN BARREL AND METAL INDEX DIRECTLY. SBDM IMPLEMENT 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND ALSO RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE SBDM STRENGTH INSPECTION FOR 20ML STOPPER AND WE ARE MONITORING THE LEAKAGE OF THE 20ML SYRINGE FOR EVERY LOT NO. BY STRENGTHEN INSPECTION METHOD. SBDM CHECK AND RECONFIRMING OF INJECTION WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR GASKET MOLD. SBDM MANUFACTURED TEST SAMPLES OF 20ML SYRINGE ((B)(4)), AND GET CONFIRMATION THAT THERE WAS NO ISSUE FROM BD KOREA (BD KOREA HAD SENT THE TEST SAMPLES TO VARIOUS CUSTOMERS FOR EVALUATION). CONCLUSION: BASED ON INVESTIGATIONS, ROOT CAUSE POINT OUT TO: BROKEN TIP - SBDM CHECK SYRINGE ASSEMBLY PROCESS, IT IS ASSUMED THE BROKEN TIP IN THE SYRINGE OCCURRED WHILE THE BARREL WAS SET INTO POSITION FOR PRINTING PROCESS IN THE ASSEMBLY MACHINE INDEX. WHILE THE BARREL WAS BEING SET INTO POSITION FOR PRINTING PROCESS, THE METAL INDEX HAD CONTACTED HARD WITH THE BARREL. THIS CAUSES DAMAGE AND SUBSEQUENTLY BROKE THE TIP OF THE SYRINGE. HOWEVER, THE CONTACT BY THE METAL INDEX WAS NOT STRONG ENOUGH TO FULLY BREAK OFF THE TIP, AND THE INSPECTOR COULDN`T FIND VISUALLY CAPTURED THIS BROKEN TIP. LEAKAGE - 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(F1.35), 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 HAVE IN HOUSE CAPA-(B)(4) (LEAKAGE) & CAPA-(B)(4) (BROKEN TIP) IN PLACE TO MONITOR DEFECT AND ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE HAD A TIP BREAK AND "BECAUSE THE GASKET WAS VERY SOFT, DRUG FLUID WAS LEAKED BACKWARD." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 GREATER ASIA, THIS SITE IS NOT REGISTERED WITH THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE HAD A TIP BREAK AND "BECAUSE THE GASKET WAS VERY SOFT, DRUG FLUID WAS LEAKED BACKWARD." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495751 BD¿ SYRINGE SYRINGE FMF BECTON DICKINSON 1802242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other