BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9309211 · Received November 12, 2019

    Report

    Report Number
    1920898-2019-01266
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1/2CC SYRINGES. CUSTOMER STATES THAT THE SYRINGES CAME WITH THE BENT NEEDLE, COMMENTED THAT ONE OF THEM HAD THE ORANGE PROTECTIVE SHIELD PUNCTURED AS IF THE NEEDLE HAD GONE THROUGH, TRIED TO USE ONE OF THE SYRINGES EVEN WITH THE BENT NEEDLE BUT COULD NOT ASPIRATE THE PRODUCT. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED A BENT CANNULA, ONE OF WHICH WAS BENT THROUGH THE SHIELD. THE REMAINING SAMPLE WAS TESTED AND WAS ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8092788 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. 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 (BENT CANNULA, CANNULA THROUGH SHIELD). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DIFFICULT/UNABLE TO OPERATE). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 09DEC2019, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FROM MATERIAL 324917, BATCH 8092788. VISUAL INSPECTION OF THE PICTURES SHOWED TWO SYRINGES, BOTH WITH THE CANNULA BENT AT AN ANGLE TO ONE SIDE. ONE OF THE SYRINGES HAD THE VERY TIP OF THE CANNULA POKING THROUGH THE SIDE OF THE SHIELD. PROCESS SUMMARY: RACKS LOADED WITH HUBS TRAVEL DOWN A CONVEYOR TOWARDS THE CANNULATOR. THEY APPROACH THE CANNULATOR TURNING HORIZONTALLY IN ORDER TO RECEIVE CANNULA. RACKS PASS UNDER MARS MAGNET STRAIGHTENING THE CANNULA IN THE HUBS. THE RACK PASSES UNDER TWO ULTRAVIOLET LAMPS, WHICH CAUSES THE ADHESIVE TO CURE. THEN THE RACKS GO TO THE SHIELDER WITH THE USE OF LINEAR MOTION. THE RACK LOCATER POSITIONS THE RACKS WHILE GETTING SHIELDED. THE PARTS ARE FIRST INSPECTED WITH AN ANGULARITY CAMERA, AND IF THE ANGLE OF THE CANNULA IS TOO GREAT OR THERE IS NOTHING ON THAT PIN, THE PART IS NOT SHIELDED. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THE NEEDLE WAS BENT AND COULD NOT ASPIRATE THE PRODUCT. ONE SHIELD WAS PUNCTURED WITH THE NEEDLE STICKING THROUGH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WE CONTACTED THE CAREGIVER REGARDING A COMPLAINT, REPORTED THAT IT USES THE SYRINGES OF BD ULTRA-FINE 6MM CAPACITY 50UI (8092788C FAB05 / 2018 VAL04 / 2023). TO APPLY HORMONE TO HER DAUGHTER, BUY THE CLOSED BOX WITH 10 PACKS OF SYRINGE AND IN ONE PACK TWO SYRINGES CAME WITH THE BENT NEEDLE, COMMENTED THAT ONE OF THEM HAD THE ORANGE PROTECTIVE SHIELD PUNCTURED AS IF THE NEEDLE HAD GONE THROUGH, TRIED TO USE ONE OF THE SYRINGES EVEN WITH THE BENT NEEDLE BUT COULD NOT ASPIRATE THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDITIONAL PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THE NEEDLE WAS BENT AND COULD NOT ASPIRATE THE PRODUCT. ONE SHIELD WAS PUNCTURED WITH THE NEEDLE STICKING THROUGH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE CONTACTED THE CAREGIVER REGARDING A COMPLAINT, REPORTED THAT IT USES THE SYRINGES OF BD ULTRA-FINE 6MM CAPACITY 50UI (8092788C FAB05 / 2018 VAL04 / 2023). TO APPLY HORMONE TO HER DAUGHTER, BUY THE CLOSED BOX WITH 10 PACKS OF SYRINGE AND IN ONE PACK TWO SYRINGES CAME WITH THE BENT NEEDLE, COMMENTED THAT ONE OF THEM HAD THE ORANGE PROTECTIVE SHIELD PUNCTURED AS IF THE NEEDLE HAD GONE THROUGH, TRIED TO USE ONE OF THE SYRINGES EVEN WITH THE BENT NEEDLE BUT COULD NOT ASPIRATE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103302 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 8092788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other