BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED GETTING STARTED KIT

    MDR report key: 9963718 · Received April 15, 2020

    Report

    Report Number
    1920898-2020-00378
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 26, 2020
    Report Date
    May 7, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT UNSPECIFIED GETTING STARTED KIT WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 4121950. IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING. EVENT DESCRIPTION PER SNOW CASE STATES: SPOKE TO NURSE WHO PROVIDED EXPIRATION DATE OF 2019 ON THE BOX OF THE"GETTING STARTED KIT". STATED THE BOX HAD SYRINGES, LANCETS, AND DEX 4 GLUCOSE TABLETS. WHEN ASKED FOR ADDITIONAL INFORMATION NURSE STATED " I REALLY DON'T HAVE THE TIME FOR THAT RIGHT NOW" AND THEN CALL ENDED. RECEIVED VOICEMAIL FROM NURSE STATING EXPIRATION DATES ARE MISSING FROM PRODUCTS. 15-APR: ADDITIONAL LINES WERE ADDED TO THE PRODUCT GRID TO CAPTURE THE LANCET AND GLUCOSE TABLETS. WHICH WERE INCLUDED IN THE KIT. ONLY ONE COMPLAINT IS BEING CAPTURED FOR THESE THREE PRODUCTS, TWO PRODUCTS WITH UNKNOWN CATALOG NUMBER. D.1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED GETTING STARTED KIT MULTIPLE CATALOG & LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.2. MEDICAL DEVICE CATALOG #: 324911 D.4. MEDICAL DEVICE LOT #: 4121950 D.4. MEDICAL DEVICE EXPIRATION DATE: N/A H.4. DEVICE MANUFACTURE DATE: 2014-06-24. D.2. MEDICAL DEVICE CATALOG #: UNKNOWN D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 4121950. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE ADDED TO PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED GETTING STARTED KIT WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 4121950. IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING. EVENT DESCRIPTION PER SNOW CASE STATES: SPOKE TO NURSE WHO PROVIDED EXPIRATION DATE OF 2019 ON THE BOX OF THE"GETTING STARTED KIT". STATED THE BOX HAD SYRINGES, LANCETS, AND DEX 4 GLUCOSE TABLETS. WHEN ASKED FOR ADDITIONAL INFORMATION NURSE STATED " I REALLY DON'T HAVE THE TIME FOR THAT RIGHT NOW" AND THEN CALL ENDED. RECEIVED VOICEMAIL FROM NURSE STATING EXPIRATION DATES ARE MISSING FROM PRODUCTS. 15-APR: ADDITIONAL LINES WERE ADDED TO THE PRODUCT GRID TO CAPTURE THE LANCET AND GLUCOSE TABLETS. WHICH WERE INCLUDED IN THE KIT. ONLY ONE COMPLAINT IS BEING CAPTURED FOR THESE THREE PRODUCTS, TWO PRODUCTS WITH UNKNOWN CATALOG NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED GETTING STARTED KIT WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 4121950. IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING. EVENT DESCRIPTION PER SNOW CASE STATES: SPOKE TO NURSE WHO PROVIDED EXPIRATION DATE OF 2019 ON THE BOX OF THE"GETTING STARTED KIT". STATED THE BOX HAD SYRINGES, LANCETS, AND DEX 4 GLUCOSE TABLETS. WHEN ASKED FOR ADDITIONAL INFORMATION NURSE STATED " I REALLY DON'T HAVE THE TIME FOR THAT RIGHT NOW" AND THEN CALL ENDED. RECEIVED VOICEMAIL FROM NURSE STATING EXPIRATION DATES ARE MISSING FROM PRODUCTS. 15-APR: ADDITIONAL LINES WERE ADDED TO THE PRODUCT GRID TO CAPTURE THE LANCET AND GLUCOSE TABLETS. WHICH WERE INCLUDED IN THE KIT. ONLY ONE COMPLAINT IS BEING CAPTURED FOR THESE THREE PRODUCTS, TWO PRODUCTS WITH UNKNOWN CATALOG NUMBER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. 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 · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10BAG 500CS WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 4121950. IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING. EVENT DESCRIPTION PER SNOW CASE STATES: SPOKE TO NURSE WHO PROVIDED EXPIRATION DATE OF 2019 ON THE BOX OF THE "GETTING STARTED KIT". STATED THE BOX HAD SYRINGES, LANCETS, AND DEX 4 GLUCOSE TABLETS. WHEN ASKED FOR ADDITIONAL INFORMATION NURSE STATED " I REALLY DON'T HAVE THE TIME FOR THAT RIGHT NOW" AND THEN CALL ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429589 UNSPECIFIED GETTING STARTED KIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 SEE H.10 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other