BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 17877323 · Received October 5, 2023

    Report

    Report Number
    1911916-2023-00737
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 22, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP, IT WAS REPORTED THERE WAS RESISTANCE IN THE PLUNGER. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. ON NOVEMBER 16, 2023, BD ISSUED A PRODUCT ADVISORY FOR THE BD POSIFLUSH SALINE SYRINGE WITH GENERAL PUMP COMPATIBILITY. THROUGH CUSTOMER COMPLAINTS, BD CONFIRMED THAT AN INCORRECT STOPPER WAS USED IN NINE LOTS, INCLUDING LOT 3226388, OF 10ML BD POSIFLUSH¿ NORMAL SALINE FLUSH SYRINGES WITH GENERAL PUMP COMPATIBILITY. THE USE OF BD POSIFLUSH PREFILLED FLUSH SYRINGES, CATALOG NUMBER 306547, WITH THIS STOPPER CAUSES AN INCREASE IN INJECTION FORCE, WHICH HAS THE POTENTIAL TO TRIGGER ALARMS IF USED WITH A SYRINGE PUMP. THE PRODUCT HAS BEEN VALIDATED AND IS ACCEPTABLE FOR MANUAL USE PER IFU (INSTRUCTIONS FOR USE). BD HAS IDENTIFIED A ROOT CAUSE AND INITIATED CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS ISSUE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOTS 3117567, 3142757, AND 3226388. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FOR LOT 3226388, PLEASE SEE THE ATTACHED PRODUCT ADVISORY AND FOLLOW THE ACTIONS REQUIRED. IF YOU NEED ANY FURTHER ASSISTANCE, PLEASE CONTACT THE NORTH AMERICAN REGIONAL COMPLAINT CENTER.

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DATE OF MANUFACTURE FOR EACH LOT: 3117567 - 2023-04-27 3142757 - 2023-05-22 3226388 - 2023-08-14 DEVICE PROBLEM CODE: A0509 - PHYSICAL RESISTANCE / STICKING (2578/1597) PATIENT PROBLEM CODE: NOT PATIENT INVOLVEMENT H3 OTHER TEXT : NA

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 306547, BATCH #: 3117567, 3142757, 3226388. IT WAS REPORTED BY THE CUSTOMER THAT TWO ADDITIONAL LOTS REPORTED: 3117567 3142757 I JUST PUT A NEW (B)(4) TO CAPTURE 3117567, 3042757 BASED OFF AN EMAIL CHAIN FROM 9/22/2023. CAN WE ADD THAT MISSING LOT 3226388 TO THIS ONE? VERBATIM: PLEASE SEE EMAIL BELOW FROM (B)(4) TO CARDINAL FOR THE LOTS THEY TESTED/SHOULD NOT USE. TWO ADDITIONAL LOTS REPORTED: 3117567 3142757 I JUST PUT A NEW (B)(4) TO CAPTURE 3117567, 3042757 BASED OFF AN EMAIL CHAIN FROM 9/22/2023. CAN WE ADD THAT MISSING LOT 3226388 TO THIS ONE? RESPONSE RECEIVED 04 OCT 2023: THE FAILURE MODE IS RESISTANCE IN PLUNGER. THE DEFECT WAS NOTICED PRIOR TO PATIENT USE. THIS MAY HAVE BEEN A TYPO AS IT IS NOT COMING UP AS A VALID LOT NUMBER.

    Description of Event or Problem · 0

    MATERIAL #: 306547 BATCH #: 3117567, 3142757, 3226388 IT WAS REPORTED BY THE CUSTOMER THAT TWO ADDITIONAL LOTS REPORTED: 3117567 3142757 I JUST PUT A NEW PR 8998039 TO CAPTURE 3117567, 3042757 BASED OFF AN EMAIL CHAIN FROM 9/22/2023. CAN WE ADD THAT MISSING LOT 3226388 TO THIS ONE? VERBATIM: PLEASE SEE EMAIL BELOW FROM FAIRVIEW TO CARDINAL FOR THE LOTS THEY TESTED/SHOULD NOT USE. TWO ADDITIONAL LOTS REPORTED: 3117567 3142757 I JUST PUT A NEW (B)(4) TO CAPTURE 3117567, 3042757 BASED OFF AN EMAIL CHAIN FROM 9/22/2023. CAN WE ADD THAT MISSING LOT 3226388 TO THIS ONE? RESPONSE RECEIVED 04 OCT 2023 THE FAILURE MODE IS RESISTANCE IN PLUNGER. THE DEFECT WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272011 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3226388 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown