BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 21G 1-1/4IN

    MDR report key: 8489882 · Received April 7, 2019

    Report

    Report Number
    2243072-2019-00673
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 29, 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

    INVESTIGATION: TWO SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1811062. RETURNED SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 2 RETURNED 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. RETURNED SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. LEAKAGE TEST BY AIR PRESSURE: SBDM CONDUCTED LEAK TEST OF THE COMPLAINT SAMPLES RECEIVED BY AIR PRESSURE UNDER 0.72MPA, THERE WAS NO LEAKAGE IN THE 2 RECEIVED SAMPLES. DIMENSION MEASUREMENT: FOR THE 2 RETURNED SAMPLES, SBDM MEASURED 4 PCS FOR 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 F20.027, F20.017, STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.042, F21.037 LEAK TEST RESULTS BY DIFFERENT BATCH OF STOPPER RAW MATERIAL: SBDM CONDUCTED THE LEAKAGE TEST ON 1,500 SAMPLES FROM 2 DIFFERENT BATCH OF STOPPER RAW MATERIAL, AFTER ALL MANUFACTURING PROCESS INCLUDED STERILIZATION. THERE WAS NO LEAKAGE IN A RAW MATERIAL LOT NO. 20190304-1 BUT, FOUND 2 LEAKAGE SAMPLE IN A RAW MATERIAL LOT NUMBER 20190311-1. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM HOUSE SAMPLE LOTS 1810114, 1811062, 1811072, NO LEAKAGE WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1811062, NO ABNORMALITY WAS OBSERVED. FROM INVESTIGATION OF RETURNED SAMPLES, SBDM COULDN`T FIND AIR ASPIRATION IN THE COMPLAINT SAMPLES. THE INNER DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER IS IN SPEC FOR THE COMPLAINT SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SYRINGE 20ML 21G 1-1/4IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "LEAKAGE THRU THE STOPPER AND PLUNGER"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: 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 (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SYRINGE 20ML 21G 1-1/4IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "LEAKAGE THRU THE STOPPER AND PLUNGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283105 SYRINGE 20ML 21G 1-1/4IN SYRINGE FMF BECTON DICKINSON 1811062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other