BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 11373484 · Received February 24, 2021

    Report

    Report Number
    9616657-2021-00025
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/26/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0223175. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, UNUSED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE REPRESENTATIVE SAMPLES WERE INSPECTED AND NO ISSUES WITH PLUNGER MOVEMENT WERE IDENTIFIED WHEN THE PLUNGER WAS PRESSED DOWNWARDS. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 10ML REG PR SALINE 10ML FILL HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED SALINE FLUSHES ARE NOT FLUSHING WHEN ATTACHED TO AN IV CATHETER. VERBATIM: BD TEAM, I SPOKE TO PRODUCT COMPLAINS () I AM RECEIVING MANY COMPLAINTS WITH THESE 10CC SALINE FLUSHES. ITEM 306546. THEY ARE NOT FLUSHING WHEN ATTACHED TO AN IV CATHETER. I AM COPYING MY CUSTOMER () LOTS: 0223175 , 0154213, 0188331. THIS NEEDS TO BE ADDRESSED IMMEDIATELY AS THEY HAVE OVER 30 LOCATIONS WITH THESE LOTS. PLEASE ADVISE DATED OF EVENTS FOR THE ATTACHED COMPLAINTS: MD DATE OF EVENT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (2 OCCURRENCES LOT 0154213 AND LOT 0188331) DATE OF EVENT: (B)(6) 2021. FROM CUSTOMER EMAIL 27-JAN THIS LOT# OF 10ML NS SYRINGES IS HAVING AN ISSUE WITH FLUSHING ONCE ATTACHED TO THE ANGIOCATH. IT CAN STILL ASPIRATE BUT IS UNABLE TO FLUSH. IT FLUSHES FINE WHEN ATTACHED TO THE EXTENSION SET ALONE."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 10ML REG PR SALINE 10ML FILL HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED SALINE FLUSHES ARE NOT FLUSHING WHEN ATTACHED TO AN IV CATHETER. VERBATIM: BD TEAM, I SPOKE TO PRODUCT COMPLAINS (). I AM RECEIVING MANY COMPLAINTS WITH THESE 10CC SALINE FLUSHES. ITEM 306546. THEY ARE NOT FLUSHING WHEN ATTACHED TO AN IV CATHETER. I AM COPYING MY CUSTOMER (). LOTS: 0223175, 0154213, 0188331, THIS NEEDS TO BE ADDRESSED IMMEDIATELY AS THEY HAVE OVER 30 LOCATIONS WITH THESE LOTS. PLEASE ADVISE. DATED OF EVENTS FOR THE ATTACHED COMPLAINTS: MD. (B)(6). FROM CUSTOMER EMAIL 27-JAN: THIS LOT# OF 10ML NS SYRINGES IS HAVING AN ISSUE WITH FLUSHING ONCE ATTACHED TO THE ANGIOCATH. IT CAN STILL ASPIRATE BUT IS UNABLE TO FLUSH. IT FLUSHES FINE WHEN ATTACHED TO THE EXTENSION SET ALONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268663 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON, DICKINSON AND CO. 306546 0223175 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1