BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL

    MDR report key: 11757533 · Received April 30, 2021

    Report

    Report Number
    1911916-2021-00391
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0170206 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-05-31 H4: DEVICE MANUFACTURE DATE: 2020-06-18 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 0170206. 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. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL EXPERIENCED A SYRINGE THAT WAS DAMAGED/CRACKED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "CORONARY ATHEROSCLEROTIC HEART DISEASE" ON (B)(6) 2021. AFTER ADMISSION, HE WAS GIVEN INTRAVENOUS INFUSION THERAPY AND INTRAVENOUS INDWELLING NEEDLES WERE USED FOR PUNCTURE INFUSION. (B)(6) 2021 AFTER THE PATIENT USED THE INTRAVENOUS INDWELLING NEEDLE FOR INFUSION, WHEN THE CATHETER WAS SEALED FOR THE INDWELLING NEEDLE, THE TUBE WAS ROUTINELY FLUSHED, AND THE FLUSH WAS USED TO FLUSH THE TUBE. WHEN THE TUBE WAS FLUSHED, IT IS FOUND THAT THE FLUSH WAS CRACKED AND CANNOT BE CONTINUED. AFTER USE, THE NEW ONE WAS IMMEDIATELY REPLACED TO COMPLETE THE OPERATION WITHOUT CAUSING ADVERSE EFFECTS ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 0715450. WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL EXPERIENCED A SYRINGE THAT WAS DAMAGED/CRACKED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "CORONARY ATHEROSCLEROTIC HEART DISEASE" ON (B)(6) 2021. AFTER ADMISSION, HE WAS GIVEN INTRAVENOUS INFUSION THERAPY AND INTRAVENOUS INDWELLING NEEDLES WERE USED FOR PUNCTURE INFUSION. (B)(6) 2021 AFTER THE PATIENT USED THE INTRAVENOUS INDWELLING NEEDLE FOR INFUSION, WHEN THE CATHETER WAS SEALED FOR THE INDWELLING NEEDLE, THE TUBE WAS ROUTINELY FLUSHED, AND THE FLUSH WAS USED TO FLUSH THE TUBE. WHEN THE TUBE WAS FLUSHED, IT IS FOUND THAT THE FLUSH WAS CRACKED AND CANNOT BE CONTINUED. AFTER USE, THE NEW ONE WAS IMMEDIATELY REPLACED TO COMPLETE THE OPERATION WITHOUT CAUSING ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650202 SYRINGE 5ML SALINE FILL PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0170206

    Patients

    Seq Age Sex Outcome Treatment
    1