BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10071375 · Received May 19, 2020

    Report

    Report Number
    2243072-2020-00791
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 3, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: SITE LEGAL NAME (FDA): (B)(4). B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. D.2. COMMON DEVICE NAME: PISTON SYRINGE. D.3. MEDICAL DEVICE MANUFACTURER: HOLDREGE. D.2. MEDICAL DEVICE CATALOG #: 328440. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. D.4. MEDICAL DEVICE LOT #: 8260803. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2020-05-19. G.1. MANUFACTURING LOCATION: HOLDREGE. G.5. PMA/510(K)#: K024112. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.3. DEVICE EVAL BY MANUFACTURER: YES. H.4. DEVICE MANUFACTURE DATE: 2018-09-17. H.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 SHIELD DOES NOT DETACH AS INTENDED, NEEDLE HUB DIMENSION (LARGER) AND NEEDLE BREAKS OFF DURING USE (IN VIAL) ON LOT # 8260803 INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8260803. CUSTOMER STATES THAT THEY ARE HAVING DIFFICULTY REMOVING THE NEEDLE SHIELD FROM THE SYRINGE AND ADDITIONALLY, IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING CANNULA AND ADHESIVE RUNOFF ONTO THE HUB. THE ADHESIVE RUNOFF COULD CAUSE THE SHIELD TO BE DIFFICULT TO REMOVE. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8260803 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200779743, 200779545] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION 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 (ADHESIVE RUNOFF AND MISSING CANNULA). 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: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1614260, "ON 9TH JUN 2020, HOLDREGE RECEIVED PHOTO SAMPLE OF 0.3 ML 31*8MM INSULIN SYRINGE FROM LOT: 8260803. COMPLAINT FROM THE CUSTOMER STATES THAT THEY ARE HAVING DIFFICULTY REMOVING THE NEEDLE SHIELD FROM THE SYRINGE AND ADDITIONALLY, IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE SYRINGE. THE ADHESIVE RUNOFF COULD CAUSE THE SHIELD TO BE DIFFICULT TO REMOVE. A VISUAL EVALUATION OF THE PHOTO SAMPLE EXHIBITS THAT IT IS ADHESIVE RUN OFF ON TO HUB AND MISSING CANNULA. PROCESS SUMMARY: ¿ THE RACKS CARRYING THE HUB WITH CANNULA MOVE FURTHER DOWN ALONG A RAIL, A PULLOUT DEVICE MOVES THE CANNULA OUT A SMALL DISTANCE FOR ADHESIVE TO BE APPLIED. ¿ DURING THE PARTS PASS UNDER THE CORONA TREATER PINS AND EXPOSED TO AN ION RICH CORONA FIELD, WHICH INCREASES SURFACE ENERGY WETTABILITY TO AID IN THE ADHESION OF THE ADHESIVE TO THE HUB. ¿ THE CANNULA IS THEN RE-INSERTED INTO THE HUB WITH VACUUM. ¿ THE PIM INSPECTION SYSTEMS LOOKS FOR ADHESIVE CLOGS, SPLATTER AND REJECTS THE NEEDLE ASSEMBLIES IN THE PROCESS. REVIEWED DHR RECORDS, LOGBOOKS & MAINTENANCE HISTORY FROM SAP DID NOT FIND ANY POTENTIAL CAUSES/ ADJUSTMENTS TO THE PROCESS. THERE WERE TWO (2) NOTIFICATIONS [200779743, 200779545] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. NO ROOT CAUSE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE BREAK OCCURRED WITH BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED DIFFICULTY REMOVING THE NEEDLE SHIELD FROM ONE INSULIN SYRINGE DUE TO THE NEEDLE HUB BEING LARGER THEN USUAL. STATED THAT WHEN DRAWING HER INSULIN FROM THE VIAL THE NEEDLE ALSO BROKE OFF FROM THE SYRINGE AND THE NEEDLE FELL INTO HER INSULIN VIAL. STATED SHE IS USING THE 3/10 ML, 1/2 UNIT MARKING, 8MM X 31G INSULIN SYRINGES."

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG OR A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE BREAK OCCURRED WITH A UNSPECIFIED BD NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED DIFFICULTY REMOVING THE NEEDLE SHIELD FROM ONE INSULIN SYRINGE DUE TO THE NEEDLE HUB BEING LARGER THEN USUAL. STATED THAT WHEN DRAWING HER INSULIN FROM THE VIAL THE NEEDLE ALSO BROKE OFF FROM THE SYRINGE AND THE NEEDLE FELL INTO HER INSULIN VIAL. STATED SHE IS USING THE 3/10 ML, 1/2 UNIT MARKING, 8MM X 31G INSULIN SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536914 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8260803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other