BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 9250090 · Received October 29, 2019

    Report

    Report Number
    3002682307-2019-00572
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 16, 2019
    Report Date
    November 25, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1810131 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE MATERIAL USED TO MANUFACTURE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE TIP COULD BREAK BECAUSE OF THE STRONG CONDITIONS DURING USE OF THE PRODUCT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THERE WERE CRACKS IN THE BARREL OF SYRINGE WITH A BD SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: FOUND THAT THE BARREL OF THE SYRINGE HAS CRACKS.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THERE WERE CRACKS IN THE BARREL OF SYRINGE WITH A BD SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FOUND THAT THE BARREL OF THE SYRINGE HAS CRACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048181 BD SYRINGE S2 5ML 22GA 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1810131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other