BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALI NE 10ML FIL

    MDR report key: 18632762 · Received February 2, 2024

    Report

    Report Number
    1911916-2024-00052
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 8, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP IT WAS REPORTED, UPON VERIFICATION OF HEMODIALYSIS CATHETER PATENCY, THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE FILLED WITH APPROXIMATELY 3.5ML OF BLOOD. THERE ARE DROPS OF BLOOD OVER THE SYRINGE RUBBER STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THE PREFILLED SYRINGE IS DESIGNED TO PUSH THE PLUNGER ROD-RUBBER STOPPER DOWN UNTIL THE SALINE SOLUTION HAS BEEN EXPELLED. AFTER, THE UNIT SHOULD BE DISCARDED. THE PRODUCT IS NOT DESIGNED TO CONTINUE USE BY PULLING THE PLUNGER ROD-RUBBER STOPPER BACK TO ASPIRATE BLOOD OR ANY OTHER SOLUTION. IF THE PRODUCT IS NOT MEETING THE CUSTOMER¿S NEEDS, IT MAY BE BENEFICIAL TO CONTACT THE LOCAL BD SALES, OR MARKETING REPRESENTATIVE, FOR ADDITIONAL PRODUCT OPTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT 3090897. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT 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 THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 306547 BATCH#: 3090897 IT WAS REPORTED BY CUSTOMER THAT UPON VERIFICATION OF HD CATHETER PATENCY THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). THE PATIENT WAS ALSO SOILED WITH BLOOD. QUESTIONABLE CONTAMINATION OF BLOOD? BLOOD NOT RETURNED TO PATIENT. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. UPON VERIFICATION OF HD CATHETER PATENCY THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). THE PATIENT WAS ALSO SOILED WITH BLOOD. QUESTIONABLE CONTAMINATION OF BLOOD? BLOOD NOT RETURNED TO PATIENT.

    Description of Event or Problem · 0

    MATERIAL #: 306547 BATCH#: 3090897 IT WAS REPORTED BY CUSTOMER THAT UPON VERIFICATION OF HD CATHETER PATENCY THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). THE PATIENT WAS ALSO SOILED WITH BLOOD. QUESTIONABLE CONTAMINATION OF BLOOD? BLOOD NOT RETURNED TO PATIENT. NO PATIENT HARM VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. UPON VERIFICATION OF HD CATHETER PATENCY THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). THE PATIENT WAS ALSO SOILED WITH BLOOD. QUESTIONABLE CONTAMINATION OF BLOOD? BLOOD NOT RETURNED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622676 SYR 10ML PUMP COMPATIBLE SALI NE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3090897 30382903065470
    2136161 SYR 10ML PUMP COMPATIBLE SALI NE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3090897 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown