BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 17442493 · Received August 2, 2023

    Report

    Report Number
    9616657-2023-00029
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 30, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    NGT
    UDI-DI
    00382903065530
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 2243740. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR (4) SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. TWO (2) OF THE BLISTER PACKAGES WERE SEPARATED AND OPENED WITH THE SYRINGES STILL INSIDE. THE REMAINING TWO (2) SYRINGES WERE SEPARATED, AND THE BLISTER PACKAGES WERE OPENED. THROUGH THE INSPECTION, WE CAN CONFIRM THAT THE MOST PROBABLE CAUSE FOR THIS ISSUE WAS FIBER TEARING. A SMALL AMOUNT OF FIBER TEARING NATURALLY OCCURS WHEN SEPARATING INDIVIDUAL BLISTERS AND WHEN SEPARATING THE PAPER TOP WEB FROM THE PLASTIC BOTTOM WEB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE PACKAGING TORE WHILE OPENING AND LEFT PAPER SHARDS IN THE STERILE FIELD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THE CHADS FROM THE PERFORATION ARE FLAKING ONTO THE STERILE FIELD. WHEN THEY'RE OPENED FROM PAPER PACK, SOME OF THE PAPER SEEMS TO BE FLAKING OFF ONTO THE STERILE FIELD. THEY ARE NOT SURE THE EXACT AMOUNT SO FAR THAT HAVE HAD THE ISSUE. IS THERE ANY ADVERSE EVENT OCCURRED? NO IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NO".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE PACKAGING TORE WHILE OPENING AND LEFT PAPER SHARDS IN THE STERILE FIELD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THE CHADS FROM THE PERFORATION ARE FLAKING ONTO THE STERILE FIELD. WHEN THEY'RE OPENED FROM PAPER PACK, SOME OF THE PAPER SEEMS TO BE FLAKING OFF ONTO THE STERILE FIELD. THEY ARE NOT SURE THE EXACT AMOUNT SO FAR THAT HAVE HAD THE ISSUE... -IS THERE ANY ADVERSE EVENT OCCURRED? NO. -IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385058 BD POSIFLUSH¿ SF SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON DE MEXICO 2243740 00382903065530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown