BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 8975944 · Received September 9, 2019

    Report

    Report Number
    2243072-2019-01957
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 13, 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 · 0

    H.6. INVESTIGATION: INVESTIGATIONS: 3 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1904172. COMPLAINT SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 3 SAMPLES AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. - WHEN PULLED OBLIQUELY, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. COMPLAINT SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. VISUAL INSPECTION BY PROFILE PROJECTOR: SBDM CONDUCTED VISUAL INSPECTION BY A PROFILE PROJECTOR, HOLE WAS DISCOVERED IN THE CENTER OF GASKET OF THE RETURNED SAMPLES. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOTS 1904152, 1904172 AND 1905133, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1904172, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATIONS, THE LEAKAGE ON THE RETURNED SAMPLES 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 WAS OCCURRED IN THE STOPPER INJECTION PROCESS. THE FLOW OF THE STOPPER RAW MATERIAL WAS NOT ENOUGH IN TEMPORARY 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEDICATION LEAKED PAST THE PLUNGER WITH A BD SYRINGE 20ML 18G 1-1/2IN. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER WAS USING 20ML SYRINGE, THE FLUID WAS LEAKED BACK OF PLUNGER.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS GREATER ASIA IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICATION LEAKED PAST THE PLUNGER WITH A BD SYRINGE 20 ML 18G 1-1/2 IN. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER WAS USING 20 ML SYRINGE, THE FLUID WAS LEAKED BACK OF PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772088 BD SYRINGE 20ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1904172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other