BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

    MDR report key: 11664890 · Received April 14, 2021

    Report

    Report Number
    3006948883-2021-00384
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-12 H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8043015. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALSO, WITH THE SAMPLES PROVIDED TO US BY THE FACILITY, OUR ENGINEERS WERE ABLE TO IDENTIFY AGING OF THE SEPTUM AS THE MOST LIKELY ROOT CAUSE FOR THIS EVENT. THE SEPTUM IS EXPECTED TO COMPLETELY CLOSE AFTER THE REMOVAL OF THE CANNULA, THIS SEAL PREVENTS THE LEAKAGE OF THE DEVICE. DURING OUR EVALUATION, THE SEPTUM WAS FOUND TO BE OPEN. FROM PREVIOUS INVESTIGATIONS WE KNOW, THAT AS THE SEPTUM AGES, THE SEPTUM WILL LOSE ELASTICITY. EXPERIMENTAL TESTING OF SEPTUMS IN HOT OF DRY ENVIRONMENTS DETERMINED THAT THE SEPTUM WILL AGE, LOSING ITS ELASTICITY AND ULTIMATELY FAILING TO SUCCESSFULLY CLOSE AFTER CANNULA REMOVAL. IN RESPONSE TO THIS EVENT WE HAVE NOTIFIED OUR CONTRACTED SHIPPING COMPANIES, AND RECOMMUNICATED BD'S EXPECTATIONS FOR THE IMPLEMENTATION OF ENVIRONMENTAL CONTROLS, DURING SHIPMENT AND STORAGE OF OUR DEVICES. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC LEAKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOUBLE CHECKED WITH SALES REP, ADDITIONAL INFORMATION GOT AS BELOW ON 2021-04-12, THE NURSE USED ONE NEW PRODUCT TO FINISH THE OPERATION. THE NURSE ALWAYS WEAR GLOVE TO OPERATE AND THERE IS NO RISK TO TOUCH BLOOD. AS FACT, THE PATIENT HAD NO HURT AND IMPACT IN THE CASE. AND THE NURSE HAD NO HURT AND IMPACT BY THE CASE. ********************************************************************************* NURSES IN CT ROOM USED THIS BATCH NEEDLE DURING PIERCING, BLOOD LEAKAGE HAPPENED OCCASIONALLY AT THE SEPTUM, SO HIGH-PRESSURE IMAGING COULDN'T CONTINUE, AND IT AFFECTED THE NORMAL USE, CUSTOMER HAD NO CHOICE BUT TO PUNCTURE, CURRENTLY, THERE WERE 6 NEEDLE WITH THIS PROBLEM THAT HAD BEEN FOUND. ALTHOUGH THE CUSTOMER HAD REASSURED PATIENTS AND OTHER MEDICAL PERSONNEL IN THE DEPARTMENT, IT WOULD BE DIFFICULT TO SOLVE IF THIS PROBLEM HAPPENED AGAIN, AND IT WOULD BE REFLECTED IN THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC LEAKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOUBLE CHECKED WITH SALES REP, ADDITIONAL INFORMATION GOT AS BELOW ON 2021-04-12, THE NURSE USED ONE NEW PRODUCT TO FINISH THE OPERATION. THE NURSE ALWAYS WEAR GLOVE TO OPERATE AND THERE IS NO RISK TO TOUCH BLOOD. AS FACT, THE PATIENT HAD NO HURT AND IMPACT IN THE CASE. AND THE NURSE HAD NO HURT AND IMPACT BY THE CASE. NURSES IN CT ROOM USED THIS BATCH NEEDLE DURING PIERCING, BLOOD LEAKAGE HAPPENED OCCASIONALLY AT THE SEPTUM, SO HIGH-PRESSURE IMAGING COULDN'T CONTINUE, AND IT AFFECTED THE NORMAL USE, CUSTOMER HAD NO CHOICE BUT TO PUNCTURE, CURRENTLY, THERE WERE 6 NEEDLE WITH THIS PROBLEM THAT HAD BEEN FOUND. ALTHOUGH THE CUSTOMER HAD REASSURED PATIENTS AND OTHER MEDICAL PERSONNEL IN THE DEPARTMENT, IT WOULD BE DIFFICULT TO SOLVE IF THIS PROBLEM HAPPENED AGAIN, AND IT WOULD BE REFLECTED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564744 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC CATHETER FOZ BD (SUZHOU) 0078909

    Patients

    Seq Age Sex Outcome Treatment
    1