BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G ETW X 7MM PEN NEEDLE US

    MDR report key: 10010190 · Received April 29, 2020

    Report

    Report Number
    1920898-2020-00442
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382904736989
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8100673, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-04-10. MEDICAL DEVICE LOT #: 8100674, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-04-10. (B)(6) INVESTIGATION SUMMARY: LEVEL A 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 DIMENSION ON LOT # 8100673 & 8100674. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) OPEN 7MM, 23G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THERE IS A QUESTION ON THE ID MEASUREMENTS. BOTH RETURNED PEN NEEDLES WERE SCANNED USING THE CT SCANNER IN ORDER TO MEASURE THE ID ON THE PATIENT END AND NON PATIENT END OF THE CANNULA OF BOTH SAMPLES. ALL MEASUREMENTS FALL WITHIN SPECIFICATIONS AND NO DEFECTS WERE OBSERVED ON EITHER OF THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8100674. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8100673. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. 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 23G ETW X 7MM PEN NEEDLE US HAD AN INJECTION FORCE FAILURE. THIS OCCURRED ON 7 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RECORD IS BEING RAISED FOR NOTIFICATION TO UNDERSTAND THE SUPPLIER CONTROLS SURROUNDING NEEDLE ID TESTING. THE BATCHES REFERENCED IN THIS RECORD PASSED INCOMING INSPECTION AND WERE RELEASED FOR USE IN COMMERCIAL PRODUCTION. INJECTION FORCE (IF) FAILURE DURING FINISHED DEVICE RELEASE TESTING RESULTED IN PT&D TO EXAMINE THE NEEDLE ID WITH A PIN GAUGE (DIAMETER .04597 ± 0.005 MM). THE PIN GAUGE ONLY CHECKS THAT THE ID IS LARGER THAN THE PIN GAUGE BUT DOES NOT PROVIDE VARIABLE DATA. IT WAS THEN DECIDED TO SEND A SMALL SAMPLE SIZE OF NEEDLES OUT FOR MEASUREMENT VIA CT SCANNING. THE DCP NEEDLE CANNULA ID IS SPECIFIED ON THE NEEDLE SPECIFICATION AT 0.0190¿ ¿ 0.0205¿ AND IS DEFINED AS A DEFECT ON THE BD CUSTOMER SPECIFICATION. 8 DCP NEEDLES USED DURING RELEASE IF TESTING WERE SENT FOR CANNULA ID MEASUREMENTS VIA CT SCANNING. 11 MEASUREMENTS WERE TAKEN PER NEEDLE. OF THE 88 MEASUREMENTS TAKEN, ALL 88 WERE FOUND BELOW THE MINIMUM DESIGN TOLERANCE (MIN ¿ 0.0190¿ = 0.483 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476180 23G ETW X 7MM PEN NEEDLE US PEN NEEDLE FMI BD MEDICAL - DIABETES CARE 4736989 SEE H.10 00382904736989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other