BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML SYRINGE LUER-LOK TIP

    MDR report key: 9723254 · Received February 18, 2020

    Report

    Report Number
    1911916-2020-00167
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 4, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: 4 SAMPLES WERE RECEIVED. THEY CAME IN SEALED PACKAGING BLISTER. THEY WERE VISUALLY INSPECTED FINDING NO DEFECTS. FIRST THEY WERE TESTED FOR SUSTAINING FORCE HAVING FROM 1.8LB TO 2.2LB THE PROCESS SPECIFICATION IS <2.5LB. THEN THEY WERE TESTED FOR LEAKAGE AND THEY ALL PASSED WITH NO LEAKAGE NOTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. THIS IS THE 1ST COMPLAINT FOR LOT # 9240505 FOR THIS TYPE OF DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER IS TIGHT AND SYRINGE LEAKS AS THE PLUNGER IS DIFFICULT TO USE WITH A BD 20ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE GASKET IS TIGHT AND LEAKS WHEN IT IS FULL. IT WAS ALSO REPORTED THE PLUNGER IS VERY STIFF WHEN PULLING UPWARDS. ADDITIONALLY, ON 2/5/2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ON WHAT DATE(S) DID THE INCIDENT OCCUR? HOW MANY TIMES HAS THE REPORTED ISSUE OCCURRED? THIS IS AN ONGOING PROBLEM THAT IS RELATED TO ALL OF THE PRODUCT RCVD FROM BD-WE HAD USED THIS PRODUCT IN THE PAST THEN STOPPED DUE TO THE DIFFICULTY WITH PULLING THE PLUNGER ONE HANDED-VERY STIFF. WE WENT TO (B)(6) AND HAD NO DIFF WITH THEIR SUPPLY. WE RCVD YOUR SYRINGES AS A STOP-GAP WHEN WE WERE NOT ABLE TO GET SUPPLY FROM HS. WHAT IS THE BD LOT/BATCH NUMBER OF THE AFFECTED PRODUCT? LOT # 9240505. ARE ANY PATIENT IDENTIFIERS AVAILABLE? (E.G. AGE, WEIGHT, GENDER, INITIALS, ETC.)N/A. IS THE AFFECTED DEVICE OR REPRESENTATIVE SAMPLES FROM THE SAME LOT AVAILABLE TO BE SENT TO BD FOR EVALUATION? YES. DID THE REPORTED ISSUE RESULT IN ANY HARM/INJURY, CHANGE/CANCELLATION OF TREATMENT, OR MEDICAL INTERVENTION? NO. DID THE REPORTED ISSUE OF LEAKAGE RESULT IN EXPOSURE TO SKIN OF BLOOD OR HAZARDOUS MEDICATION? NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187522 BD 20ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 9240505 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other