BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 17981490 · Received October 20, 2023

    Report

    Report Number
    1911916-2023-00789
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE CAPS OF SALINE FLUSH SYRINGES HAVE A BROWN RESIDUE. TO AID IN THE INVESTIGATION, THERE SAMPLES IN SEALED PACKAGING FLOW WRAPS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE TIP CAPS HAVE A DISCOLORATION THAT APPEARS TO BE LUBRICANT FROM THE MOLDING PRESS. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, DURING A REPAIR OR PREVENTATIVE MAINTENANCE, THE MOLDING PRESS/TOOL WAS NOT PROPERLY CLEANED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3142760. 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. THE SAMPLES WILL BE SHOWN TO THE ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND WITH THE RETURNED 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 BECOMES AVAILABLE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 306546 BATCH#: 3142760. IT WAS REPORTED BY THE CUSTOMER THAT CAPS OF SALINE FLUSH SYRINGES HAVE BROWN RESIDUE IN SEALED PACKAGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COREWELL HEALTH EXPERIENCED A PRODUCT DEFECT TODAY IN ONE OF OUR CLINICS. PLEASE START THE QUALITY PROCESS FOR THIS EVENT. HERE ARE THE RELEVANT DETAILS: EVENT DATE: 10-13-23. EVENT LOCATION: (B)(6). EVENT DESCRIPTION: CAPS OF SALINE FLUSH SYRINGES HAVE BROWN RESIDUE IN SEALED PACKAGES. PRODUCT DESCRIPTION: ITM-1103194 - SYRINGE SALINE POSIFLUSH 10ML 30/PK. PRODUCT REF: 306546. LOT NUMBER: 3142760. PHOTO OF DEFECT IS ATTACHED; WORKING TO MAKE A SAMPLE AVAILABLE FOR EVALUATION. BD CUSTOMER ACCOUNT NUMBER: (B)(4). IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE CAPS? THE RESIDUE SEEMS TO BE SMEARED IN THE CAPS AND ENDS OF THE SYRINGES, NOT ABLE TO BE REMOVED EASILY. 2. ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES, PHYSICAL SAMPLES AVAILABLE. PHOTO IS ATTACHED. THE PRODUCT CAN BE OBTAINED BY SENDING A LABEL TO THIS ADDRESS: (B)(6). 3. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THESE ITEMS WERE NOT UTILIZED ON A PATIENT, SO NO ADVERSE OUTCOMES.

    Description of Event or Problem · 0

    MATERIALS#: 306546 BATCH#: 3142760 . IT WAS REPORTED BY THE CUSTOMER THAT CAPS OF SALINE FLUSH SYRINGES HAVE BROWN RESIDUE IN SEALED PACKAGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COREWELL HEALTH EXPERIENCED A PRODUCT DEFECT TODAY IN ONE OF OUR CLINICS. PLEASE START THE QUALITY PROCESS FOR THIS EVENT. HERE ARE THE RELEVANT DETAILS: EVENT DATE: (B)(6) 2023. EVENT LOCATION: (B)(6). EVENT DESCRIPTION: CAPS OF SALINE FLUSH SYRINGES HAVE BROWN RESIDUE IN SEALED PACKAGES. PRODUCT DESCRIPTION: ITM-1103194 - SYRINGE SALINE POSIFLUSH 10ML 30/PK. PRODUCT REF: 306546. LOT NUMBER: 3142760. PHOTO OF DEFECT IS ATTACHED; WORKING TO MAKE A SAMPLE AVAILABLE FOR EVALUATION. BD CUSTOMER ACCOUNT NUMBER: (B)(6). IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE CAPS? THE RESIDUE SEEMS TO BE SMEARED IN THE CAPS AND ENDS OF THE SYRINGES, NOT ABLE TO BE REMOVED EASILY. 2. ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES, PHYSICAL SAMPLES AVAILABLE. PHOTO IS ATTACHED. THE PRODUCT CAN BE OBTAINED BY SENDING A LABEL TO THIS ADDRESS: (B)(6). 3. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THESE ITEMS WERE NOT UTILIZED ON A PATIENT, SO NO ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995968 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142760 30382903065463
    2150252 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142760 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown