BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 10898748 · Received November 24, 2020

    Report

    Report Number
    1920898-2020-01622
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0013346. D.4. MEDICAL DEVICE EXPIRATION DATE: H.4. DEVICE MANUFACTURE DATE: 2020-02-19. D.4. MEDICAL DEVICE LOT #: 0139917. D.4. MEDICAL DEVICE EXPIRATION DATE: . H.4. DEVICE MANUFACTURE DATE: 2020-06-26 . D10: DEVICE AVAILABLE FOR EVAL YES,. D10: RETURNED TO MANUFACTURER ON: 2020-12-04. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED SIX (6) 31GX8MM, 1ML INSULIN SYRINGES (5 FROM AN OPEN POLYBAG FROM LOT 0139917, AND 1 LOOSE). CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED FROM SITE NEEDLE BROKE OFF IN SITE. THE 1 SYRINGE RETURNED LOOSE WAS EXAMINED, AND IT WAS OBSERVED THAT THE SYRINGE EXHIBITED A BROKEN CANNULA; THE FRACTURED CANNULA WAS ALSO RETURNED BY THE CUSTOMER. MICROSCOPIC EXAMINATION OF THIS SYRINGE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE HUB-END OF THE FRACTURED CANNULA, AND OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. THE OTHER 5 SYRINGES WERE TESTED FOR POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G CANNULA: 0.0100¿- 0.0105¿): DATA: POINT OUTER DIAMETER (IN.) LUBE SAMPLE 1 GOOD 0.0103 GOOD; SAMPLE 2 GOOD 0.0103 GOOD; SAMPLE 3 GOOD 0.0103 GOOD; SAMPLE 4 GOOD 0.0103 GOOD; SAMPLE 5 GOOD 0.0103 GOOD. ALL 5 TESTED SYRINGES TESTED WITHIN SPECIFICATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0139917. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED FOR THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013346. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (CANNULA BROKEN): USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON BOTH ENDS OF THE FRACTURED CANNULA, AND OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE BROKE OFF OF SYRINGE IN SITE. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED FROM SITE NEEDLE BROKE OFF IN SITE. TWO DIFFERENT DAYS. PET OWNER ABLE TO REMOVE FROM SITE WITH HIS FINGERS. DENIED REUSE OF ITEMS. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT NEEDLE BROKE OFF OF SYRINGE IN SITE. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED FROM SITE NEEDLE BROKE OFF IN SITE. TWO DIFFERENT DAYS. PET OWNER ABLE TO REMOVE FROM SITE WITH HIS FINGERS. DENIED REUSE OF ITEMS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362756 SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328506 SEE H10 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1