BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 17952525 · Received October 17, 2023

    Report

    Report Number
    1911916-2023-00778
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 2, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6): 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE FLUSH WAS CONTAMINATED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE TIP CAP HAS DISCOLORATION THAT APPEARS TO THE LUBRICANT FROM THE MOLDING PRESS. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE 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. THE SAMPLE WAS SENT TO A LABORATORY FOR ADDITIONAL ANALYSIS. THE TESTING CONFIRMED THE FOREIGN MATTER WAS NOT BLOOD. HOWEVER, THE HIGHEST PERCENT MATCH OF THE FOREIGN MATTER TO KNOWN SUBSTANCES WAS NOT CONCLUSIVE, SO IT IS NOT POSSIBLE TO CONFIRM WHAT THE FOREIGN MATTER IS FROM THE TESTING. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MAT# 306546, LOT# 3142760. IT WAS REPORTED BY THE CUSTOMER THAT THE NURSING STAFF DISCOVERED A SALINE FLUSH THAT WAS STILL IN THE WRAPPER, BUT LOOKED LIKE IT WAS CONTAMINATED. THE NURSE PROMPTLY BROUGHT THE SUSPECT PRODUCT TO THE PHARMACY. VERBATIM : RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE NURSING STAFF DISCOVERED A SALINE FLUSH THAT WAS STILL IN THE WRAPPER, BUT LOOKED LIKE IT WAS CONTAMINATED. THE NURSE PROMPTLY BROUGHT THE SUSPECT PRODUCT TO THE PHARMACY CATALOG #: 306546, LOT #: 3142760. ADDITIONAL INFORMATION: ADDITIONAL INFO RECEIVED ON 16-OCT-23 IT APPEARS TO BE A DRIED LIQUID CONTAMINATE. NOT IN THE SYRINGE BARREL BUT ON THE LUER LOCK TIP AND CAP. IT IS A MUTED RED COLOR. HONESTLY, LOOKS LIKE DRIED BLOOD. I HAVE ATTACHED A PICTURE AND AM MORE THAN WILLING TO SHIP IT TO YOU FOR FURTHER INSPECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MAT# 306546 LOT# 3142760. IT WAS REPORTED BY THE CUSTOMER THAT THE NURSING STAFF DISCOVERED A SALINE FLUSH THAT WAS STILL IN THE WRAPPER, BUT LOOKED LIKE IT WAS CONTAMINATED. THE NURSE PROMPTLY BROUGHT THE SUSPECT PRODUCT TO THE PHARMACY. VERBATIM : RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE NURSING STAFF DISCOVERED A SALINE FLUSH THAT WAS STILL IN THE WRAPPER, BUT LOOKED LIKE IT WAS CONTAMINATED. THE NURSE PROMPTLY BROUGHT THE SUSPECT PRODUCT TO THE PHARMACY. CATALOG #: 306546. LOT #: 3142760. ADDITIONAL INFO RECEIVED ON 16-OCT-23: IT APPEARS TO BE A DRIED LIQUID CONTAMINATE. NOT IN THE SYRINGE BARREL BUT ON THE LUER LOCK TIP AND CAP. IT IS A MUTED RED COLOR. HONESTLY, LOOKS LIKE DRIED BLOOD. I HAVE ATTACHED A PICTURE AND AM MORE THAN WILLING TO SHIP IT TO YOU FOR FURTHER INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199125 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142760 30382903065463
    96611 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142760 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown