BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 7793630 · Received August 17, 2018

    Report

    Report Number
    2243072-2018-01145
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    June 1, 2018
    Report Date
    September 21, 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

    H.6. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED TO SBDM, THE COMPLAINT LOT NUMBER IS 1802242. RETURNED SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST USING 5 PCS RETENTION SAMPLES FROM LOT 1802242 AND RESULTS ARE: 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 SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. WHEN PULLED OBLIQUELY, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. 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. BARREL INTERNAL DIAMETER: SPEC F20.05 +/- 0.05MM. SAMPLES WERE MEASURED AT F20.044, F20.037, F20.084, F20.097, F20.080. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.031, F21.049, F21.010, F21.018, F21.025. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORDS FOR POSSIBLE LOT 1802242. NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL COMPLAINT RECORD FOR SAME SKU, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. INVESTIGATION CONCLUSION: FROM INVESTIGATIONS, 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(F1.35), 50ML(F1) SYRINGE IS MORE THAN F1.0 BUT THE INTERFERENCE FIT OF 20ML SYRINGE IS F0.95). THIS MAY BE ATTRIBUTED TO MOLDED STOP 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 CHANGED RAW MATERIAL SUPPLIER FOR STOPPER DUE TO DISCONTINUITY BY CURRENT SUPPLIER ((B)(4) SINCE NOV 2017. SBDM QUALIFIED ALTERNATIVE MATERIAL BY ANOTHER SUPPLIER ((B)(4)), CONDUCTED VALIDATION INCLUDING LEAKAGE, MOVING FORCE, DEAD SPACE, EXTRACTABLE TEST AND ASSEMBLY TEST. THE VALIDATION WERE COMPLETED NOV 2017, AND VALIDATION RESULTS WERE ACCEPTABLE. SBDM STARTED MASS PRODUCTION SINCE FEB 2018 WITH ALTERNATIVE MATERIAL. FROM THE COMPLAINTS ON SYRINGE LEAKAGE/AIR ASPIRATION, SBDM DISCOVERED THE CUSTOMERS ARE NOT USING THE SYRINGE SAME AS THEIR LEAKAGE TEST METHOD (MOVING A PLUNGER STRAIGHTLY BY TESTING MACHINE). SO, SBDM WILL ENHANCED LEAKAGE TEST METHOD TO ALIGN WITH CUSTOMER`S USING CONDITION. FINALLY, SBDM HAS CONDUCTED A RE-VALIDATION OF INJECTION PROCESS AND CONCLUDED THE OPTIMAL STOPPER INJECTION CONDITION HAD CHANGED DURING MASS PRODUCTION AS COMPARED TO THE CONDITION ACHIEVED WITH VALIDATION PRIOR TO MASS PRODUCTION. SBDM WILL CONTINUED TO MANUFACTURE THE STOPPER USING THE NEW OPTIMAL INJECTION CONDITION ACHIEVED THROUGH RE-VALIDATION 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 ENHANCING INSPECTION METHOD (SIMILAR WITH CUSTOMER¿S USING CONDITION). 3. SBDM ARE CHECKING AND RECONFIRMING OF INJECTION WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR GASKET MOLD. 4. SBDM CONDUCTED RE-VALIDATION OF INJECTION PROCESS FOR STOPPER, WHEN IT IS COMPLETED, MANUFACTURED TEST SAMPLES OF 20ML SYRINGE (36,000EA) AND GET CONFIRMATION THAT THERE WAS NO ISSUE FROM BD KOREA. 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 FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH THE USE OF THE BD¿ SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636527 BD¿ SYRINGE SYRINGE FMF BECTON DICKINSON 1802242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other