BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 ML WITH 25X1

    MDR report key: 10687382 · Received October 15, 2020

    Report

    Report Number
    2243072-2020-01655
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 19, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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: 10/16/2020 H.6. INVESTIGATION: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED (21) DISCARDIT 2ML WITH 25X1¿ FROM LOT # 0091161 AND PRODUCT # 301866 WITH THE REPORTED ISSUE OF ¿SYRINGES RECEIVED WITH FOREIGN PRACTICAL, HAIR, BLISTER LEAKAGE, MARKING DEFECTS. OUT OF (B)(4) UNITS SUPPLIED (B)(4) UNITS ARE REJECTED¿. DHR REVIEWED FOUND NO NON-CONFORMITIES. 21 SAMPLES HAVE BEEN RECEIVED BY BD FOR INVESTIGATION. THE SAMPLES WERE TESTED FOR DEFECTS FOR INVESTIGATION OF THE COMPLAINTS. BASED ON THE INVESTIGATION DONE ON THE RECEIVED SAMPLES BY THE INVESTIGATION TEAM, THE DEFECTS ARE VISIBLE. THE DEFECTS ARE CONFIRMED. THE MULTIPLE DEFECTS HAPPENED DUE TO MULTIPLE ISSUES THAT OCCURRED AT DIFFERENT OCCASION DURING PRODUCTION OF THIS LOT. 1 AND 2. BLACK SPOT & FOREIGN PARTICLE ¿ RCA- THIS DEFECT OCCURS DUE TO SYRINGE GETTING RUBBED WITH EACH OTHER WHEN SYRINGES ARE PUT IN HOPPER AND IT IS OVERFILLED. ACTION PLAN TO PREVENT THIS DEFECT FROM REOCCURRING 1. IDENTIFIED AND MARKED THE LEVEL TO SET THE HOPPER ON A POINT THAT OPERATOR SHOULD NOT OVERFILL THE SYRINGES. 2. IMPLEMENTED CLEANING PROCESS OF BRUSH USED IN SYRINGE LOADERS 3. INTRODUCTION OF PM SCHEDULE FOR SYRINGE LOADER I) INCLUDE THE CLEANING OF SLIDING PART(S) OF THE LOADER II) CLEANING OF THE PRODUCT HOLDING FINGERS OF THE LOADERS 3. CRITICAL REJECTS : A. DAMAGED BLISTER AND BLISTER LEAKAGE- RCA- BLISTER LEAKAGE COULD BE DUE TO CHAIN SLITS NOT ABLE TO HOLD POLY DURING MOVEMENT. ACTION PLAN- RE-ALIGNED THE CHAIN SLIT PARTS TO ENABLE IT TO HOLD THE POLY IN PLACE DURING MOVEMENT. B. TWO NEEDLE IN ONE PACK- RCA- NEEDLE JUMPS IN TO SEALING ZONE CAUSING DAMAGED COMPONENT AND VISION CAMERA MALFUNCTIONING CANNOT DETECT TWO NEEDLES IN ONE PACK ACTION PLAN- FREQUENCY OF CHALLENGE TEST OF THE VISION CAMERA TO BE REVISED FROM PM (WEEKLY) TO DAILY. C. NO NEEDLE IN THE PACK- RCA- NEEDLE JUMPS IN TO SEALING ZONE CAUSING DAMAGED COMPONENT AND VISION CAMERA MALFUNCTIONING CANNOT DETECT MISSING NEEDLES ACTION PLAN- FREQUENCY OF CHALLENGE TEST OF THE VISION CAMERA TO BE REVISED FROM PM (WEEKLY) TO DAILY. D. MARKING DEFECT- RCA- THIS DEFECT IS CAUSED DUE TO MIS-ALIGNMENT ON STAMPING STATION THAT CAN HAPPEN DURING MACHINE MOVEMENT. ACTION PLAN-WHILE INSPECTING THE STAMPING STATION MIS-ALIGNMENT WAS OBSERVED IN THE TOP AND BOTTOM PART OF THE STAMPING STATION. THE ALIGNMENT DONE AND ADDED THE CHECKING OF STAMPING STATION ALIGNMENT FREQUENCY ON PM CHECKLIST. E. HAIR IN PACK- RCA- HAIR FOUND IN PACK IS DUE TO FLOOR CLEANING NOT ADEQUATE AND DUE TO STATIC CHARGE HAIR GET PACKED CAVITY. ACTION PLAN- CLEANING TEAM TRAINED TO CLEAN FLOOR USING VACUUM AND FOREIGN MATERIAL LIKE HAIR ARE REMOVED. 4. WHITE PARTICLES ¿ RCA- THE WHITE PARTICLES ARE FOUND TO BE CREATED DUE TO FRICTION WHILE TRANSFERRING THE MOLDED COMPONENT TO ASSEMBLY THROUGH THE AIR CONVEYOR. ACTION PLAN-INSTALL MEECH IONIZING AND VACUUM CLEANING DEVICE TO REMOVE THE WHITE FOREIGN PARTICLE. TARGET DATE- 30/DEC/2020 H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 ML WITH 25X1¿ CONTAINED FOREIGN MATTER, HAD A DAMAGED OR OPEN UNIT SEAL, AND HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES RECEIVED WITH FOREIGN PRACTICAL, HAIR, BLISTER LEAKAGE, MARKING DEFECTS. OUT OF (B)(4) UNITS SUPPLIED (B)(4) UNITS ARE REJECTED"

    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. (B)(4). OEM MANUFACTURE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 ML WITH 25X1¿ CONTAINED FOREIGN MATTER, HAD A DAMAGED OR OPEN UNIT SEAL, AND HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES RECEIVED WITH FOREIGN PRACTICAL, HAIR, BLISTER LEAKAGE, MARKING DEFECTS. OUT OF (B)(4) UNITS SUPPLIED (B)(4) UNITS ARE REJECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152498 2 ML WITH 25X1 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0091161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other