BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GAX0.75IN PRN-QSYTEY NOPVC

    MDR report key: 18379768 · Received December 21, 2023

    Report

    Report Number
    3014704491-2023-00840
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 27, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903838622
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW: (1)THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3170889, IS 24G AND PRODUCT CODE IS 383862, PRODUCED ON 2023/07, WITH A TOTAL OF (B)(4)PIECES IN THIS BATCH; (2)THE Q-SYTE BATCH NUMBER USED IN THIS BATCH OF PRODUCTS WAS 3088210; (3)INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY; (4)CHECK THE PRODUCTION RECORDS FOR THIS BATCH OF PRODUCTS THAT THERE ARE NO NONCONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES IN THE PROCESS OF THIS BATCH OF PRODUCTS; 2.THE CUSTOMER DID NOT RETURN ANY SAMPLES AND ONLY PROVIDED A VIDEO OF THE DEFECTIVE SAMPLES. FROM THE VIDEO, IT CAN BE SEEN THAT WHILE THE PRODUCT'S PINCH CLAMP WAS OPENED, THE CUSTOMER INJECTED LIQUID FROM ONE END OF THE Y-SHAPED CONNECTOR, AND THE LIQUID OVERFLOWED FROM THE MEMBRANE OF THE Q-SYTE CONNECTOR ON THE OTHER END; 3.TAKE THE RETAINED SAMPLE OF THIS BATCH Q-SYTE FUCTION TEST , AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1; 4.THE HISTORY OF CUSTOMER COMPLAINTS FOR THE SAME BATCH OF PRODUCTS HAS BEEN REVIEWED, AND NO COMPLAINTS OF THE SAME DEFECTS HAVE BEEN FOUND. IN SUMMARY, NO ABNORMALITIES WERE FOUND DURING THE ASSEMBLY PROCESS. ACCORDING TO THE VIDEO PROVIDED BY THE CUSTOMER, IT IS SUSPECTED THAT THERE WAS QUALITY ISSUE WITH THE Q-SYTE CONNECTOR. THE FACTORY WILL CONTINUE TO MONITOR THE DEFECT. DHR: THE DHR FOR LOT 3170889 HAS BEEN REVIEWED. THIS LOT WAS BUILT AND PACKAGED ON QFA LINE 4 FROM 06-APR-2023 THROUGH 08-APR-2023 FOR A QUANTITY OF 216,000 NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. RISK REVIEW: PEURA RM5699 REVISION 07 HAS BEEN REVIEWED. THIS TYPE OF FAILURE HAS BEEN INCLUDED AND ADEQUATELY ASSESSED FOR RISK ON PAGES 1, 4, 6, 7, 8, 9, 10, 11, AND 18. AEURA RM4678 REVISION 09 HAS BEEN REVIEWED. THIS TYPE OF FAILURE HAS BEEN INCLUDED AND ADEQUATELY ASSESSED FOR RISK ON PAGES 5 AND 6. DEURA RM5818 REVISION 07 HAS BEEN REVIEWED. THIS TYPE OF FAILURE HAS BEEN INCLUDED AND ADEQUATELY ASSESSED FOR RISK ON PAGE 5. INVESTIGATION SUMMARY: RECEIVED ONE VIDEO OF A PEGASUS YEL 24GAX0.75IN PRN-QSYTEY NOPVC. THE VIDEO DISPLAYS A SYRINGE CONNECTING TO THE Y CONNECTOR AND FLUSHING THE DEVICE. THE LIQUID FLOWS OUT OF THE Q-SYTE. THIS MOST LIKELY INDICATES A LEAKAGE IN THE Q-SYTE UNIT. THE REPORTED DEFECT WAS CONFIRMED. DURING MANUFACTURING, DAMAGE TO THE SEPTUM MAY OCCUR DUE TO BURRED TOOLING, POOR BLADE QUALITY, MISALIGNMENT OF PARTS OR PROBE, OR FROM A SHARP EDGE FROM ADHESIVE BUILDUP. ADDITIONALLY, BASED ON DEURA RM5818 REVISION 07, ADHESIVE WICKING DOWN THE COLUMN MAY LEAD TO LEAKAGE. SLIT QUALITY, COLUMN TEAR CHECKS AND CONTROLLED FUNCTIONAL LEAK TESTS ARE PERFORMED OF THE FULL ASSEMBLY PER THE QUALITY CONTROL PLAN QCPA-13 REVISION 32 AND PA-23 REVISION 41 TO MITIGATE THE RISK FROM A TORN SEPTUM. ADDITIONALLY, DURING USE, EXCESSIVE ACTUATIONS, ACTUATIONS AT A WRONG ANGLE, OR EXTRANEOUS FORCE ON THE SEPTUM MAY ALSO RESULT IN TEARING OF THE SEPTUM. THE PHYSICAL DEVICE WOULD BE NEEDED FOR FURTHER INVESTIGATION FOR A DEFINITIVE ROOT CAUSE. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿LEAKAGE¿ WAS CONFIRMED. PROBABLE ROOT CAUSE: UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS YEL 24GAX0.75IN PRN-QSYTEY NOPVC ADAPTER/CONNECTOR WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HOSPITAL OF (B)(6), DEPARTMENT OF INFECTIOUS DISEASES, HEAD NURSE OU ON (B)(6) 2023 FOR THE MAINTENANCE OF PATIENTS WITH INDWELLING NEEDLES, FOUND THAT IN THE Y-SHAPED CAVITY TO PUSH THE LIQUID IN THE OTHER CAVITY OF THE DIAPHRAGM CONNECTOR SPRAYING WATER OUT, A CAREFUL OBSERVATION DID NOT FIND THAT THE CONNECTOR IS BROKEN, THE RECENT EMERGENCE OF FIVE OR SO SUCH A SITUATION, THE DEPARTMENT OF INFECTIOUS DISEASES, OCCUPATIONAL EXPOSURE TO A HIGH RISK, I HOPE THAT THE COMPANY INVESTIGATED CLEARLY, TO DRAW ATTENTION TO THE SITUATION, IF SUCH A SITUATION AGAIN WILL NOT BE PRACTICAL IN THE BD INDWELLING NEEDLES, HOPE TO FIND OUT THE REASONS AND GIVE A REPLY. GOOGLE TRANSLATION ON (B)(6) 2023, NURSE OU OF THE DEPARTMENT OF INFECTIOUS DISEASES OF THE FIFTH AFFILIATED HOSPITAL (B)(6) DISCOVERED THAT WHEN THE LIQUID WAS PUSHED INTO THE Y-SHAPED CAVITY, WATER SPRAYED OUT FROM THE SEPARATOR MEMBRANE JOINT OF THE OTHER CAVITY WHEN PERFORMING MAINTENANCE ON THE PATIENT'S INDWELLING NEEDLE. A BROKEN JOINT WAS FOUND. THIS SITUATION HAS OCCURRED ABOUT 5 TIMES RECENTLY. THERE ARE MANY PATIENTS WITH INFECTIOUS DISEASES IN THE DEPARTMENT, AND THE RISK OF OCCUPATIONAL EXPOSURE IS HIGH. I HOPE OUR COMPANY WILL INVESTIGATE CLEARLY AND PAY ATTENTION. IF THIS SITUATION OCCURS AGAIN, WE WILL NO LONGER USE BD INDWELLING NEEDLES. WE HOPE TO FIND OUT. REASONS AND RESPOND.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277935 BD PEGASUS YEL 24GAX0.75IN PRN-QSYTEY NOPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3170889 00382903838622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown