BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 11938327 · Received June 4, 2021

    Report

    Report Number
    1911916-2021-00518
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 13, 2021
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS UNABLE TO PUSH THE PLUNGER FURTHER THAN 3-6ML. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THE CUSTOMER HAD PRODUCT ON THE HIGHER END OF SPECIFICATION INDUCING MORE FORCE THAN NORMAL REQUIRED TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT NUMBER 1053528. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/12/2021. H.6. INVESTIGATION: IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS UNABLE TO PUSH THE PLUNGER FURTHER THAN 3-6ML. TO AID IN THE INVESTIGATION, ONE HUNDRED EIGHTY SIX SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THERE WERE ONE HUNDRED EIGHTY UNUSED SAMPLES AND SIX USED SAMPLES. THE SIX SAMPLES CAME IN TWO PLASTIC BAGS. THE SIX USED SAMPLES AND THIRTY TWO RANDOMLY SELECTED UNUSED SAMPLES WERE VISUALLY INSPECTED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH OF THESE SAMPLES WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE THE CUSTOMER HAD PRODUCT ON THE HIGHER END OF SPECIFICATION INDUCING MORE FORCE THAN NORMAL REQUIRED TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT NUMBER 1053528. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL PLUNGER WAS DIFFICULT TO PUSH DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORMAL SALINE FLUSH IS UNABLE TO FULLY FLUSH ALL SALINE FROM SYRINGE. RESISTANCE IS MET AFTER PUSHING 3-6ML OF SALINE AND UNABLE TO PUSH PLUNGER ANY FARTHER. THIS IS ONLY HAPPING WITH THIS ONE LOT #.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL PLUNGER WAS DIFFICULT TO PUSH DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORMAL SALINE FLUSH IS UNABLE TO FULLY FLUSH ALL SALINE FROM SYRINGE. RESISTANCE IS MET AFTER PUSHING 3-6ML OF SALINE AND UNABLE TO PUSH PLUNGER ANY FARTHER. THIS IS ONLY HAPPING WITH THIS ONE LOT #."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS UNABLE TO PUSH THE PLUNGER FURTHER THAN 3-6ML. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THE CUSTOMER HAD PRODUCT ON THE HIGHER END OF SPECIFICATION INDUCING MORE FORCE THAN NORMAL REQUIRED TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT NUMBER 1053528. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT IMPROPER SILICONE APPLICATION WITHIN THE SYRINGE BARREL CAN CREATE PLUNGER RESISTANCE. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE SILICONE APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE SILICONE IS UNIFORMLY APPLIED TO THE SYRINGE BARREL. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL PLUNGER WAS DIFFICULT TO PUSH DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORMAL SALINE FLUSH IS UNABLE TO FULLY FLUSH ALL SALINE FROM SYRINGE. RESISTANCE IS MET AFTER PUSHING 3-6ML OF SALINE AND UNABLE TO PUSH PLUNGER ANY FARTHER. THIS IS ONLY HAPPING WITH THIS ONE LOT #."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836141 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 1053528 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1