BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 18712214 · Received February 15, 2024

    Report

    Report Number
    1911916-2024-00101
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306547 AND LOT NUMBER 3090897. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PR (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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. 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 DURING THE PROCESS OF ACCESSING THE HEMODIALYSIS CATHETER, USING A BD POSI FLUSH 09% SODIUM CHLORIDE INJECTION SYRINGE LOT 3090897, WE CHECK THE TIGHTNESS OF THE ACCESS AND WHEN THE EMPLOYEE WAS IRRIGATING, THERE WAS A CRACK IN THE SYRINGE, CAUSING BLOOD SPLATTER FROM THIS PATIENT INTO THE EYE. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. DURING THE PROCESS OF ACCESSING THE HEMODIALYSIS CATHETER, USING A BD POSIFLUSH 09% SODIUM CHLORIDE INJECTION SYRINGE LOT 3090897, WE CHECK THE TIGHTNESS OF THE ACCESS AND WHEN THE EMPLOYEE WAS IRRIGATING, THERE WAS A CRACK IN THE SYRINGE, CAUSING BLOOD SPLATTER FROM THIS PATIENT INTO THE EYE RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURANT LA TECHNIQUE D'ACCÉDER LE CATHÉTER D'HÉMODIALYSE, EN UTILISANT UNE SERINGUE BD POSIFLUSH 0.9 % SODIUM CHLORIDE INJECTION # LOT 3090897, NOUS VÉRIFIONS L'ÉTANCHÉITÉ DE L'ACCÈS ET QUAND L'EMPLOYÉ À FAIRE IRRIGATION, IL AVAIT UNE CRACK DANS LA SERINGUE DONC À EU ÉCLABOUSSURE DE SANG DE CETTE PATIENTE DANS L'OEIL.

    Description of Event or Problem · 0

    MATERIAL #: 306547 BATCH#: 3090897. IT WAS REPORTED BY CUSTOMER THAT DURING THE PROCESS OF ACCESSING THE HEMODIALYSIS CATHETER, USING A BD POSI FLUSH 09% SODIUM CHLORIDE INJECTION SYRINGE LOT 3090897, WE CHECK THE TIGHTNESS OF THE ACCESS AND WHEN THE EMPLOYEE WAS IRRIGATING, THERE WAS A CRACK IN THE SYRINGE, CAUSING BLOOD SPLATTER FROM THIS PATIENT INTO THE EYE. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091924 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3090897 30382903065470
    424693 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3090897 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other