BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20ML LUER LOK SYRINGE

    MDR report key: 10175418 · Received June 19, 2020

    Report

    Report Number
    9614033-2020-00095
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION. UPON OBSERVATION, PACKAGING SEAL OF THE BLISTER PACK IS OPEN, APPEARS COMPROMISED DUE TO POOR OPENING TECHNIQUE. CORRECTIVE AND PREVENTATIVE ACTION, CAPA#1506100, HAS BEEN IMPLEMENTED. DURING THE DOCUMENTARY REVIEW IT WAS OBSERVED THAT NO QUALITY EVENTS WERE REGISTERED THAT COULD ORIGINATE THE DEFECT REPORTED BY THE CLIENT, THE LOT WAS INSPECTED AND SUBSEQUENTLY RELEASED IN ACCORDANCE WITH THE CURRENT WORK INSTRUCTION. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 20ML LUER LOK SYRINGES EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY IS COMPROMISED AND PACKAGING TEARS WHILE LEAVING PAPER SHARDS IN STERILE FIELD/ROOM. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303310, BATCH NO: UNKNOWN . PER CUSTOMER: WHAT IS THE DATE THIS ISSUE WAS DISCOVERED? A FEW WEEKS BACK. HOW MANY TIMES HAS IT HAPPENED? THE DEPARTMENT COLLECTED THE ONES THAT TORE AS EXAMPLES. WHAT IS THE LOT NUMBER? 9339635 (THE MOST COMMON), 9339638, 9100873, 9100875. WHEN OUR MEDICAL STAFF OPEN THE PACKAGE, THE PAPER RIPS WHICH THEN RENDERS THE SYRINGE NO LONGER STERILE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER OCCUPATION: VALUE ANALYSIS ANALYST, MATERIALS MANAGEMENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9339635. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2020-01-27. MEDICAL DEVICE LOT #: 9339638. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2020-01-29. MEDICAL DEVICE LOT #: 9100873. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-07-05. MEDICAL DEVICE LOT #: 9100875. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-07-05. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 20ML LUER LOK SYRINGES EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY IS COMPROMISED AND PACKAGING TEARS WHILE LEAVING PAPER SHARDS IN STERILE FIELD/ROOM. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303310 BATCH NO: UNKNOWN. PER CUSTOMER: WHAT IS THE DATE THIS ISSUE WAS DISCOVERED? A FEW WEEKS BACK. HOW MANY TIMES HAS IT HAPPENED? THE DEPARTMENT COLLECTED THE ONES THAT TORE AS EXAMPLES. WHAT IS THE LOT NUMBER? 9339635 (THE MOST COMMON), 9339638, 9100873, 9100875. WHEN OUR MEDICAL STAFF OPEN THE PACKAGE, THE PAPER RIPS WHICH THEN RENDERS THE SYRINGE NO LONGER STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636286 20ML LUER LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other