BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9520785 · Received December 26, 2019

    Report

    Report Number
    1911916-2019-01330
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO SAMPLES WERE RECEIVED. THE SAMPLES CAME IN SEALED PACKAGING BLISTER. THEY HAVE THE PLASTIC SHIELD. THE LOT# PRINTED ON IS THE LOT# 9093550. THEY HAVE THE TOP AND BOTTOM WEBS FULLY SEALED MAKING DIFFICULT TO SEPARATE THEM AND OPEN THE PACKAGING BLISTER. THIS WOULD HAVE HAPPENED DURING THE MULTIVAC PACKAGING PROCESS. THE BOTTOM WEB IS FORMED TO CREATE A KIND OF NEST AND THE PART IS PLACED IN THE "NEST". THEN THE TOP WEB IS PLACED, AND THE BLISTER IS SEALED. IN THIS CASE BOTH WEBS WERE FULLY SEALED AND NOT DETECTED DURING THE INSPECTIONS. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THE BATCH RECEIVED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD BLUNT FILL NEEDLE WITH FILTER THE PACKAGING IS DIFFICULT TO OPEN CREATING A STERILITY PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: THE PACKAGING IS DIFFICULT TO OPEN STERILE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD BLUNT FILL NEEDLE WITH FILTER THE PACKAGING IS DIFFICULT TO OPEN CREATING A STERILITY PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PACKAGING IS DIFFICULT TO OPEN STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317040 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 UNKNOWN 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other