BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM 30BOX MEX

    MDR report key: 10714493 · Received October 21, 2020

    Report

    Report Number
    9614033-2020-00145
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR STOPPER DAMAGED, THUMBPRESS BROKEN, PLUNGER CAP TIGHT, NEEDLE HUB SEPARATES, PLUNGER DIFFICULT TO MOVE AND SHIELD TIGHT ON LOT # 0062047. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, STOPPER DAMAGED, THUMBPRESS BROKEN, PLUNGER CAP TIGHT, NEEDLE HUB SEPARATES, PLUNGER DIFFICULT TO MOVE AND SHIELD TIGHT) WAS CAPTURED, AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 3/10CC, 6MM, 31G SYRINGE. CUSTOMER STATES THAT THE STOPPER IS LARGER THAN THE CYLINDER AND THAT MAKES IT DIFFICULT TO EXTRACT THE INSULIN, THE TIGHTLY GLUED SHIELD, THE SYRINGES ARE BROKEN, THE PLUNGER CAP IS GLUED, AND THE THUMB PRESS CAME BROKEN. THE PHOTO WAS EXAMINED, AND EXHIBITED A SYRINGE WITH THE THUMB PRESS BROKEN. NONE OF THE OTHER NOTED DEFECTS WERE OBSERVED IN THE PHOTOS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062047. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN THUMB PRESS). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES, SHIELD/PLUNGER CAP DIFFICULT TO REMOVE, STOPPER DAMAGED, PLUNGER DIFFICULT TO MOVE). ROOT CAUSE DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1920550, "ON (B)(6) 2020, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE. VISUAL INSPECTION OF THE PICTURE FOUND (1) SYRINGES WITH A BROKEN THUMBPRESS. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.3ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 6MM 30BOX MEX HAD DEFORMED STOPPERS, DIFFICULT PLUNGER MOVEMENT, AND BROKEN THUMB PRESSES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ONCE AGAIN I HAVE FOUND DEFECTIVE AND IN NOT GOOD CONDITIONS SYRINGES. THE PROBLEM WITH THE STOPPER CONTINUES, THE PLUNGER CAP IS GLUED AND GIVES THE IDEA TO BE SEALED WITH GLUE, ONCE IT IS TOO DIFFICULT REMOVE IT. IN SOME CASES, THE SYRINGE BREAKS BECAUSE IT IS SO TIGHTLY SEALED. NOW WE MUST ADD THAT THE THUMB PRESS CAME BROKEN. THE CUSTOMER ON OTHER OCCASIONS HAS ALREADY REPORTED THE SAME FAILURE IN THE PRODUCT. (B)(4). INFO ADD RECEIVED: THE PRODUCT IS COMPLETELY DEFECTIVE, THE PROBLEM THAT I HAVE REPORTED ON MULTIPLE OCCASIONS IS: THE STOPPER IS LARGER THAN THE CYLINDER AND THAT MAKES IT DIFFICULT TO EXTRACT THE INSULIN, I HAVE REPORTED IT IN THE PAST BUT THE PROBLEM CONTINUES. BEFORE IT USED TO PASS 1 SYRINGE FOR EVERY 50, BUT NOW IT IS MORE FREQUENT, TO THAT WE MUST ADD THAT THEY BRING MORE DEFECTS SUCH AS THE TIGHTLY GLUED SHIELD. EACH PACKAGE I BUY HAS AT LEAST 2 DEFECTIVE UNITS. INFO ADD RECEIVED (09-29-2020): CUSTOMER REPORTS "THE STOPPER IS LARGER THAN THE BARREL, THAT MAKES IT VERY DIFFICULT TO EXTRACT THE INSULIN SINCE MORE FORCE HAS TO BE APPLIED, WHEN THAT METHOD DOES NOT WORK I HAVE TO DISCARD THE DEFECTIVE SYRINGE . NOT ONLY WITH THE STOPPER, I HAVE ALSO REPORTED THAT SYRINGES WITHOUT NEEDLES, THE TIGHTLY SEALED SHIELD WHICH BREAKS THE SYRINGE SO TIGHTLY SEALED THAT IT COMES, IN DETAIL, I BOUGH A BOX WITH 3 BAGS OF 10 UNITS EACH ONE, AS USUAL I OPEN THE BAG AND TAKE A SYRINGE TO INJECT MYSELF LIKE EVERY DAY. AT THE TIME OF REMOVING THE SHIELD AND PROCEEDING TO EXTRACT THE INSULIN, HE NOTICED THAT IT IS NOT POSSIBLE TO EXTRACT THE INSULIN SINCE THE STOPPER IS STUCK, WHEN APPLYING MORE FORCE I REALIZE THAT THE STOPPER IS LARGER THAN THE TUBE AND THEREFORE IT IS NOT POSSIBLE TO MOVE FREELY, ALSO REPORTED THAT THE SYRINGES ARE BROKEN AND I ATTACHED A PHOTO WHERE I SHOW HOW THE SYRINGES ARE BROKEN." FOR NEEDLE MISSING IT WAS OPENED PR # (B)(4))."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180594 SYRINGE 0.3ML 31G 6MM 30BOX MEX PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 0062047

    Patients

    Seq Age Sex Outcome Treatment
    1