BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CAN SP

    MDR report key: 18928929 · Received March 19, 2024

    Report

    Report Number
    1911916-2024-00194
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    January 15, 2024
    Report Date
    April 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    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

    (B)(4) FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3173798. 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. ALL BD POSIFLUSH¿ PRE-FILLED SYRINGES ARE DESIGNED TO ENSURE MAXIMUM PATIENT SAFETY. THE STOPPER AND PLUNGER ROD HAVE SPECIAL DESIGN FEATURES WHICH STOP PULL-BACK ON THE PLUNGER ROD, WHICH MAY HAVE ALLOWED THE STOPPER TO TRAVEL BEHIND ITS ORIGINAL PARKED LOCATION AND ENTER A NON-STERILE REGION. THIS SAFETY MECHANISM PREVENTS THE SOLUTION FROM ENTERING A NON-STERILE AREA OF THE SYRINGE, HELPING TO REDUCE THE RISK OF SOLUTION CONTAMINATION AND THEREBY ENSURING PATIENT SAFETY. PULLING BACK ON THE PLUNGER ROD, EITHER BEFORE, DURING OR AFTER THE ADMINISTRATION OF SALINE FLUSH MAY LEAD TO PLUNGER ROD BEING SEPARATED FROM THE STOPPER, ESPECIALLY WHEN THE PLUNGER ROD IS TWISTED DURING PULL-BACK MOTION. 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 9878634: 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#: 306546 BATCH#:3173798 IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD NO BLOOD RETURN FROM PATIENTS LATERAL LUMEN OF DOUBLE PORT-A-CATH. WRITER ATTEMPTED TO TURBULENT FLUSH WITH PREFILLED SALINE SYRINGE (X2) AND EACH TIME THE PLUNGER BECAME UNSCREWED/DETACHED FROM BLACK RUBBER STOPPER. PLUNGER CAME ALL THE WAY OUT OF SYRINGE EACH TIME. LOT#3173798 FOR EACH SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: (B)(4) HOSPITAL COMPLAINT REFERENCE #: SIMS EVENT #:(B)(4). CUSTOMER (HOSPITAL) NAME: XXXXXXXXXXXX CUSTOMER ADDRESS:XXXXXXXXXXX, XXXXXXXXXXXX CONTACT NAME: XXXXXXX PHONE: XXXXXXX E-MAIL: XXXXXXXX CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD306592 DESCRIPTION OF PRODUCT: SYRINGE 10ML SALINE FILL 30EA/BX 16BX/CA LOT OR S/N:(B)(6) COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: 15 JAN 2024 HOSPITAL COMPLAINT REFERENCE #: SIMS EVENT #:(B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): NO BLOOD RETURN FROM PATIENTS LATERAL LUMEN OF DOUBLE PORT-A-CATH. WRITER ATTEMPTED TO TURBULENT FLUSH WITH PREFILLED SALINE SYRINGE (X2) AND EACH TIME THE PLUNGER BECAME UNSCREWED/DETACHED FROM BLACK RUBBER STOPPER. PLUNGER CAME ALL THE WAY OUT OF SYRINGE EACH TIME. LOT#3173798 FOR EACH SYRINGE. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: A FEW TIMES CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 2 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY:

    Description of Event or Problem · 0

    MATERIAL#: 306546 BATCH#:3173798 IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD NO BLOOD RETURN FROM PATIENTS LATERAL LUMEN OF DOUBLE PORT-A-CATH. WRITER ATTEMPTED TO TURBULENT FLUSH WITH PREFILLED SALINE SYRINGE (X2) AND EACH TIME THE PLUNGER BECAME UNSCREWED/DETACHED FROM BLACK RUBBER STOPPER. PLUNGER CAME ALL THE WAY OUT OF SYRINGE EACH TIME. LOT#3173798 FOR EACH SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: PCS240313GPXTZI HOSPITAL COMPLAINT REFERENCE #: SIMS EVENT #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6). CUSTOMER ADDRESS: (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD306592 DESCRIPTION OF PRODUCT: SYRINGE 10ML SALINE FILL 30EA/BX 16BX/CA LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: (B)(6) 2024 HOSPITAL COMPLAINT REFERENCE #: SIMS EVENT #: (B)(6). DETAILS OF COMPLAINT (REPORTED ISSUE): NO BLOOD RETURN FROM PATIENTS LATERAL LUMEN OF DOUBLE PORT-A-CATH. WRITER ATTEMPTED TO TURBULENT FLUSH WITH PREFILLED SALINE SYRINGE (X2) AND EACH TIME THE PLUNGER BECAME UNSCREWED/DETACHED FROM BLACK RUBBER STOPPER. PLUNGER CAME ALL THE WAY OUT OF SYRINGE EACH TIME. LOT#3173798 FOR EACH SYRINGE. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: A FEW TIMES CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 2 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334753 SYRINGE 10ML SALINE FILL CAN SP SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3173798 30382903065463
    2555509 SYRINGE 10ML SALINE FILL CAN SP SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3173798 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown