BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 11369404 · Received February 23, 2021

    Report

    Report Number
    9616657-2021-00022
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 20, 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 0188331 AND ONE RELATED NON-CONFORMANCE WAS DETECTED DURING THE PRODUCTION PROCESS. THERE WAS AN INTERMITTENT ISSUE WITH DRY BARRELS WHICH WAS RESOLVED AT THE TIME OF DETECTION. PRODUCT ASSOCIATED WITH THIS ISSUE WAS HELD FOR INSPECTION AND ALL AFFECTED MATERIAL SHOULD HAVE BEEN SCRAPPED. TO AID IN THE INVESTIGATION OF THIS ISSUE, UNUSED SAMPLES BELONGING TO LOT 0188331 WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETURNED SAMPLES FOR LOT 0188331 DID NOT REVEAL SIGNS OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 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

    INITIAL REPORTER INFORMATION: THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. 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 A 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. 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
    266146 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON, DICKINSON AND CO. 306546 0188331 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1