BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10 ML LL SYRINGE W/O NEEDLE

    MDR report key: 15161043 · Received August 3, 2022

    Report

    Report Number
    8041187-2022-00422
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 4, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1322080, MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026, DEVICE MANUFACTURE DATE: 18-NOV-2021. MEDICAL DEVICE LOT #: 2010677, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, DEVICE MANUFACTURE DATE: 10-JAN-2022. ONE PHOTO AND THREE ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO AND SAMPLES, THE TEAM OBSERVED A CLOUDY BOTTOM WEB. NO ABNORMALITY ON THE SEALING PORTION WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE POSSIBLE ROOT CAUSE COULD BE DUE TO AN INCOMING MATERIAL ISSUE. THE TEAM HAS ENGAGED WITH THE INCOMING QUALITY DEPARTMENT ON THIS COMPLAINT AND THE SUPPLIER INVESTIGATION HAS BEEN ISSUED TO THE PERFORM AN INVESTIGATION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B.5. MODIFIED TO MORE ACCURATELY MATCH THE EVENT TYPE IN THE DT: IT WAS REPORTED WHILE USING BD 10 ML LL SYRINGE W/O NEEDLE THE PACKAGING HAD ABNORMALITIES AND WAS DISCOLORED. THIS OCCURRED 48 TIMES IN LOT 2010677, AND 3 TIMES IN LOT 1322080. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND PACKAGING MATERIAL ABNORMALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 10 ML LL SYRINGE W/O NEEDLE THE PACKAGING HAD ABNORMALITIES. THIS OCCURRED 48 TIMES IN LOT 2010677, AND 3 TIMES IN LOT 1322080. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS DUE TO POOR WRAPPING PAPER/FOUND TRACES OF DEBRIS INSIDE THE PACKAGE ADDITIONAL INFORMATION RECEIVED (B)(6)2022: UPON CHECKING, THE CONTENT WAS WRONGLY SUBMITTED BY PIR INITIATOR. THE CUSTOMER ONLY FOUND PACKAGING MATERIAL ABNORMALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 10 ML LL SYRINGE W/O NEEDLE THE PACKAGING HAD ABNORMALITIES AND WAS DISCOLORED. THIS OCCURRED 48 TIMES IN LOT 2010677, AND 3 TIMES IN LOT 1322080. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND PACKAGING MATERIAL ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163306 BD 10 ML LL SYRINGE W/O NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown