BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 9258002 · Received October 30, 2019

    Report

    Report Number
    2243072-2019-02421
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 11, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM. FROM INVESTIGATION OF THE COMPLAINT SAMPLE, LEAKAGE WAS OBSERVED. THE LEAKAGE WAS CAUSED BY HOLE IN THE CENTER OF STOPPER. SBDM REVIEW ALL MANUFACTURING PROCESS OF THE SYRINGE 20ML 18G 1-1/2IN (LOT NO. 1904172), THE HOLE IN THE STOPPER MOST LIKELY OCCURRED IN THE STOPPER INJECTION PROCESS. THE FLOW OF THE STOPPER RAW MATERIAL WAS NOT ENOUGH DUE TO TEMPORARY MALFUNCTION AND IT CAUSED HOLE IN THE STOPPER. THE LIKELY CAUSE OF THE TEMPORARY MALFUNCTION IS DUE TO GAS WAS STOCK IN THE STOPPER MOLD IN TEMPORARY. INVESTIGATION CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1904172. COMPLAINT SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE SAMPLE AND RESULTS ARE: WHEN PULLED STRAIGHT, THE SYRINGES SHOW LEAKAGE. WHEN PULLED OBLIQUELY, THE SYRINGES SHOW LEAKAGE. COMPLAINT SAMPLES NEEDLE LEAK TEST: WHEN PULLED STRAIGHT, THE NEEDLES SHOW LEAKAGE. WHEN PULLED OBLIQUELY, THE NEEDLES SHOW LEAKAGE. VISUAL INSPECTION BY PROFILE PROJECTOR: SBDM CONDUCTED VISUAL INSPECTION BY A PROFILE PROJECTOR, WE FOUND HOLE IN THE CENTER OF GASKET WHICH WERE RECEIVED SAMPLE FROM THE CUSTOMER. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM LOT 904152, 1904172 AND 1905133, THERE WAS NO LEAKAGE IN THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1904172), THERE IS NO ABNORMALITY. CUSTOMER COMPLAINT RECORD REVIEW OF COMPLAINT SAMPLE: SBDM REVIEWED CUSTOMER COMPLAINT RECORD, THERE WAS SIMILAR ISSUE OF THE SAME PRODUCT (SYRINGE 20ML 18G 1-1/2IN) FROM OTHER CUSTOMER. (B)(4). ROOT CAUSE DESCRIPTION: FROM INVESTIGATION OF THE COMPLAINT SAMPLE, LEAKAGE WAS OBSERVED. THE LEAKAGE WAS CAUSED BY HOLE IN THE CENTER OF STOPPER. SBDM REVIEW ALL MANUFACTURING PROCESS OF THE SYRINGE 20ML 18G 1-1/2IN (LOT NO. 1904172), THE HOLE IN THE STOPPER MOST LIKELY OCCURRED IN THE STOPPER INJECTION PROCESS. THE FLOW OF THE STOPPER RAW MATERIAL WAS NOT ENOUGH DUE TO TEMPORARY MALFUNCTION AND IT CAUSED HOLE IN THE STOPPER. THE LIKELY CAUSE OF THE TEMPORARY MALFUNCTION IS DUE TO GAS WAS STOCK IN THE STOPPER MOLD IN TEMPORARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A SYRINGE 20ML 18G 1-1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REGARDING THE DRUG LEAKAGE, IS IT REFERRING TO LEAKAGE PAST STOPPER? BACKFLOW? PLEASE DESCRIBE. DRUG LEAKED TO THE BACK OF THE GASKET WHEN INJECTED INTO THE PATIENT. WHAT IS THE TYPE OF DRUG LEAK FROM SYRINGE? THIS DRUG IS THE PROPOFOL. WHO WAS EXPOSED, THE HEALTHCARE WORKER OR THE PATIENT? IT'S BEEN LEAKED TO THE HEALTHCARE WORKER. WAS THERE ANY SKIN CONTACT BECAUSE OF LEAK? THEY WERE USING GLOVES, SO THEY DIDN¿T GET ON THE SKIN DIRECTLY. WAS MEDICAL TREATMENT PROVIDED AND IF SO WHAT WAS DONE?THEY DIDN¿T GET IT ON THEIR SKIN, SO THEY WERE NOT TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052621 SYRINGE 20ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1904172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other