BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 17476507 · Received August 7, 2023

    Report

    Report Number
    9614033-2023-00075
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 20, 2023
    Report Date
    November 15, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE HUNDRED SAMPLES AND FOUR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION 96 FROM LOT 2136079, THREE FROM LOT 1299636, AND ONE FROM LOT 0226073. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT 86 SYRINGES ARE LUBRICATED WITH APPEARS TO BE AN EXCESSIVE AMOUNT OF SILICONE, AND STOPPER SEPARATION FROM PLUNGER IS OBSERVED ON TWO SYRINGES. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. QUANTIFICATION OF SILICONE PERFORMED WERE NOT WITHIN SPECIFICATION. POSSIBLE ROOT CAUSE FOR EXCESSIVE SILICONE IS ASSOCIATED WITH DAMAGE TO THE SILICONE VALVE. POSSIBLE ROOT CAUSE FOR STOPPER SEPARATION IS ASSOCIATED WITH MANUFACTURING PERSONNEL. MANUFACTURING PERSONNEL HAVE BEEN TRAINED AND NOTIFIED OF THIS INCIDENT. CLEANING OF THE SILICONE DISPENSING NOZZLES WILL TAKE PLACE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    ADDITIONAL INFORMATION RECEIVED. TO FINISH, I WILL ATTACH 1 PHOTO AFTER THE INCIDENT OCCURRED TODAY, AND I WILL ATTACH ABOUT 3 MORE WHERE WE HAVE HAD FAILURES WITH THE PLUNGER AND 1 FAILURE WITH THE PRESENCE OF LIQUID IN THE SYRINGE WITHOUT EVEN HAVING OPENED IT COULD YOU DETAIL THE SPECIFIC FAILURE THAT OCCURS IN THE PISTON? FOR EXAMPLE BROKEN, POORLY ADJUSTED, DOES NOT PROVIDE VACUUM, ETC... A: IT IS NOT BROKEN BUT IT WAS DISEMBEDDED FROM THE PLUNGER, THAT IS, WHEN PULLING IT, THEY SEPARATED. CUSTOMER SENT THE FOLLOWING INFORMATION: 2. COULD YOU DETAIL THE SPECIFIC FAILURE THAT OCCURS IN THE PISTON? FOR EXAMPLE BROKEN, POORLY ADJUSTED, DOES NOT PROVIDE VACUUM, ETC... A: IT IS NOT BROKEN BUT IT WAS DISEMBEDDED FROM THE PLUNGER, THAT IS, WHEN PULLING IT, THEY SEPARATED. 3. IS THE PISTON BELT THAT OCCURRED ON THE SAME DAY AS THE NEEDLE LEAK BELT, ARE THEY FROM THE SAME LOT AND REFERENCE? A: NO, WITH REFERENCE TO THE PISTON FAILURE THERE ARE 2 SYRINGES WITH 2 DIFFERENT LOTS (LOT: 2098925 CAD: 03/2027 AND LOT: 2136079 CAD: 03/2027). AND WITH REFERENCE TO THE ESCAPE STRIP OF THE NEEDLE (WHICH I UNDERSTAND IS WITH REFERENCE TO THE OTHER SYRINGE) ITS DATA IS LOT: 2221167 AND CAD: 07/2027. REGARDING THE FOREIGN MATTER IN THE SYRINGE: 1. WHEN DID YOU IDENTIFY THE DEVIATION? FOR EXAMPLE: PACKAGING STILL CLOSED, BEFORE USE, DURING USE, AFTER USE; A: IT WAS IDENTIFIED BY CUTTING THE SYRINGE FROM THE OTHER 4 (SPEAKING OF "HOW" THEY COME IN JOINED STRIPS OF 5 SYRINGES); SINCE IN THE FIRST INSTANCE, IT WAS APPRECIATED THAT THE NEEDLE WAS SEPARATED FROM THE SYRINGE AS SUCH, AND THAT LOOKING IN DETAIL WITHOUT OPENING THE PACKAGE, THE TRANSPARENT LIQUID WAS APPRECIATED. 2. CHARACTERISTICS/APPEARANCE OF THE LIQUID (EG WATER, DIRT, ETC¿); A: SINCE THE PACKAGING HAS NOT BEEN OPENED, WE COULD NOT SAY IF IT HAS ANY OTHER PHYSICAL CHARACTERISTICS OTHER THAN ITS TRANSPARENT COLORATION AND THAT IT DOES NOT SEEM TO HAVE ANY REMAINS OR FLOATING PARTICLES. 3. LOCATION/REGION WHERE FOREIGN MATTER WAS FOUND (EG, TIP CAP, PACKING, TIP, BASE, INSIDE, OUTSIDE, ETC.) A: INSIDE THE SYRINGE, EXACTLY REACHING THE TIP OF IT, WHERE THE NEEDLE FITS. 4. IS THERE FOREIGN MATTER EMBEDDED IN THE MATERIAL? A: NOT ON THE OUTSIDE, ONLY INTERNALLY IN THE SYRINGE. 5. DOES THE PRODUCT HAVE ANY BULGES? EG: IS IT DAMAGED, CROOKED, LEAKING, PUNCTURED? A: IT DOESN'T SEEM TO BE DAMAGED OR PERFORATED, MAYBE THE PACKAGING LOOKS WRINKLED BUT IT WAS BECAUSE WE PULLED THE PLUNGER AND CONFIRMED THAT IT WAS A LIQUID AND WAS NOT A REFLECTION OF LIGHT. 6. WAS THE PACKAGING TORN AND/OR VIOLATED? A: APPARENTLY NOT, MAYBE AS I MENTIONED IN THE PREVIOUS QUESTION, IT LOOKS WRINKLED. 7. IS THE FOREIGN MATTER IN THE PACKAGING, IS IT IN THE PLASTIC WRAP OR THE PAPER? A: IT IS IN THE PACKAGING (AND INSIDE THE SYRINGE), SINCE IT HAS NOT BEEN OPENED. 8. IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? A: YES, WE HAVE THE MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE WITH NEEDLE FOREIGN MATTER WAS FOUND. THIS IS REPORT 2 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: TO FINISH, I WILL ATTACH 1 PHOTO AFTER THE INCIDENT OCCURRED TODAY, AND I WILL ATTACH ABOUT 3 MORE WHERE WE HAVE HAD FAILURES WITH THE PLUNGER AND 1 FAILURE WITH THE PRESENCE OF LIQUID IN THE SYRINGE WITHOUT EVEN HAVING OPENED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699427 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2136079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown