BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10347917 · Received July 30, 2020

    Report

    Report Number
    1911916-2020-00696
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9074857, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2019-03-15, MEDICAL DEVICE LOT #: UNKNOWN (0042292 WAS PROVIDED, HOWEVER, THIS IS NOT A MANUFACTURED LOT FOR THIS PRODUCT), MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN." (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR LOT # 9074857 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). ROOT CAUSE DESCRIPTION: UNDETERMINED RATIONALE: CAPA NOT REQUIRED AT THIS TIME A REVIEW OF THE APPLICABLE FMEA/EURA (RM208) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE BLOOD LEAKED PAST STOPPER WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THIS OCCURRED ON 2 OCCASIONS WITH AN UNKNOWN LOT #, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BLOOD LEAKED OUT THE BACK PLUNGER OF THE SYRINGE WHILE INFUSING INTO A CATHETER, BLOOD LEAKED OUT THE BACK PLUNGER OF THE SYRINGE WHILE INFUSING INTO VASCULAR ACCESS AND BLOOD LEAKED OUT THE BACK PLUNGER OF THE SYRINGE WHILE INFUSING INTO VASCULAR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812648 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 SEE H.10 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other