BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML SALINE 3ML FILL

    MDR report key: 11311742 · Received February 10, 2021

    Report

    Report Number
    1911916-2021-00106
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 16, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065448
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-27. INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306544 AND LOT NUMBER 0230934. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, THREE PHYSICAL SAMPLES AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING FLOW WRAPS. ONE HAS A SYRINGE BARREL LABEL AND TWO DO NOT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE PHOTO PROVIDED IT SHOWS TWO SYRINGES IN THEIR PACKAGING FLOW WRAP AND BOTH DO NOT HAVE THE SYRINGE BARREL LABEL. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE STOP/START CYCLE OF THE LABELING MACHINE. IT MAY HAVE BEEN THAT THE LABEL WAS NOT PLACED AND NOT DETECTED IN THE NEXT PROCESSES. BASED ON THE INVESTIGATION WITH THE SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 SYRINGE 3ML SALINE 3ML FILL EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON OPENING A BOX OF 0.9% SODIUM CHLORIDE INJECTION ¿ BD POSIFLUSH NORMAL SALINE FLUSH SYRINGE (REF # 306544), 9 SYRINGES WERE IN THE SEALED PLASTIC OVERWRAP THAT DO NOT HAVE MARKINGS ON THE SYRINGE TO DENOTE CONTENTS, LOT, EXP, OR MEASUREMENTS. BELOW IS THE INFORMATION REGARDING THE BOX THE PRODUCT WAS IN: 0.9% SODIUM CHLORIDE INJECTION, BD POSIFLUSH SYRINGE REF # 306544 LOT 0230934M EXP 8/31/2023 NO INJURIES THAT WE ARE AWARE OF.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306544 AND LOT NUMBER 0230934. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, THREE PHYSICAL SAMPLES AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING FLOW WRAPS. ONE HAS A SYRINGE BARREL LABEL AND TWO DO NOT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE PHOTO PROVIDED IT SHOWS TWO SYRINGES IN THEIR PACKAGING FLOW WRAP AND BOTH DO NOT HAVE THE SYRINGE BARREL LABEL. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE STOP/START CYCLE OF THE LABELING MACHINE. IT MAY HAVE BEEN THAT THE LABEL WAS NOT PLACED AND NOT DETECTED IN THE NEXT PROCESSES. BASED ON THE INVESTIGATION WITH THE SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT DURING THE MACHINE STOP/ START CYCLE THE LABEL WAS NOT PLACED AND NOT DETECTED IN THE NEXT PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 SYRINGE 3ML SALINE 3ML FILL EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON OPENING A BOX OF 0.9% SODIUM CHLORIDE INJECTION  BD POSIFLUSH NORMAL SALINE FLUSH SYRINGE (REF # 306544), 9 SYRINGES WERE IN THE SEALED PLASTIC OVERWRAP THAT DO NOT HAVE MARKINGS ON THE SYRINGE TO DENOTE CONTENTS, LOT, EXP, OR MEASUREMENTS. BELOW IS THE INFORMATION REGARDING THE BOX THE PRODUCT WAS IN: " 0.9% SODIUM CHLORIDE INJECTION, BD POSIFLUSH SYRINGE REF # 306544 " LOT 0230934M EXP 8/31/2023 " NO INJURIES THAT WE ARE AWARE OF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208159 SYRINGE 3ML SALINE 3ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0230934 00382903065448

    Patients

    Seq Age Sex Outcome Treatment
    1