BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 10570672 · Received September 22, 2020

    Report

    Report Number
    1920898-2020-01282
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 7, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECT INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: THE CUSTOMER PROVIDED THIS LOT NUMBER. D.4. MEDICAL DEVICE LOT #: 9042904 D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29 H.4. DEVICE MANUFACTURE DATE: 2019-02-11

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD ULTRA-FINE?¿ II INSULIN SYRINGE HAD FOREIGN MATTER ON DEVICE CANNULA / NEEDLE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED DURING USE OF THE DEVICE "THE PHYSICIAN NOTICED THE RUSTY IN THE NEEDLE AND DISCARDED IT. THERE WAS NO PATIENT INJURY, SINCE AT THE TIME OF ASPIRATING THE BOTOX.". ADDITIONAL INFORMATION: THE CUSTOMER STATED "WE HAVE A PROBLEM WITH THE ULTRA FINE SYRINGES, THE NEEDLES ARE COMING WITHOUT THE CUT AND THE DR IS NOT BEING ABLE TO INJECT THE PRODUCT INTO THE PATIENT'S SKIN. I EVEN HAD A SYRINGE THAT CAME OUT RUSTY". QUANTITY: 5 UNITS, 4 HAVE BEEN DISCARDED AND 1 HAS BEEN SENT TO MAXWELL (THE SELLER).

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9042904, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-02-11, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 3/10CC SYRINGE. CUSTOMER STATES THAT THE NEEDLES ARE COMING WITHOUT THE CUT AND A SYRINGE WAS RUSTY. THE ATTACHED PHOTOS WERE EXAMINED AND IT APPEARS THAT THERE IS SOME MATERIAL ON THE CANNULA. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL AND IT IS DIFFICULT TO DETERMINE IF THE GEOMETRY OF THE CANNULA POINT IS PROPER SOLELY FROM THE ATTACHED PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9042904 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONCLUSION: 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 (FM ON CANNULA). ROOT CAUSE: CANNOT PROVIDE A ROOT CAUSE FOR THE MATERIAL THAT APPEARS TO BE ON THE CANNULA DUE TO IT BEING DIFFICULT TO DETERMINE THE IDENTITY OF THE MATERIAL SOLELY FROM THE PHOTO. 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 DURING USE THE BD ULTRA-FINE?¿ II INSULIN SYRINGE HAD FOREIGN MATTER ON DEVICE CANNULA / NEEDLE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED DURING USE OF THE DEVICE "THE PHYSICIAN NOTICED THE RUSTY IN THE NEEDLE AND DISCARDED IT. THERE WAS NO PATIENT INJURY, SINCE AT THE TIME OF ASPIRATING THE BOTOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035775 BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9042904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other