BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7660230 · Received July 3, 2018

    Report

    Report Number
    1920898-2018-00483
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: MALE. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE TO FRANKLIN LAKES. CUSTOMER STATES THAT THE SCALE PRINT SMUDGES WHEN HE WIPES THE SYRINGES WITH ALCOHOL SWABS. THE RETURNED SYRINGE WAS TESTED AND THE SAMPLE DID NOT MEET SPECIFICATIONS REGARDING SCALE PRINT ADHESION. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 20JUL2018 FOR FURTHER REVIEW. ON 26JU2018, HOLDREGE RECEIVED ONE (1) LOOSE 0.3ML SYRINGE FROM REPORTED BATCH#: 7240810. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. DURING MANUFACTURING OF A BATCH, SYRINGES ARE TESTED FOR INK PERMANENCE; FOR BATCH#: 7240810, ALL INSPECTIONS WERE NOTED TO BE COMPLETED AND WITHOUT DEFECTS NOTED. PER THE COMPLAINANT, SYRINGES ARE REUSED AND THE EXTERIOR WIPED WITH ALCOHOL SWABS, PRESUMABLY REPEATEDLY AS THE SYRINGES ARE USED MORE THAN ONE (1) TIME. DUE TO THIS INFORMATION, IT IS UNCLEAR IF THE PROCESS DESCRIBED BY THE COMPLAINANT IS AN ATTRIBUTABLE CAUSE FOR THE SMEARING SCALE PRINT. WITHOUT ADDITIONAL INFORMATION ON THE PRODUCT USED ON THE EXTERIOR OF THE BARREL, THE INTERACTION OF THE ALCOHOL SWAB AND THE SCALE PRINTS IS UNABLE TO BE VERIFIED. PROBABLE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME, AS EXTERNAL FACTORS, AS DESCRIBED BY THE COMPLAINANT, MAY BE ATTRIBUTABLE TO THE DEFECT NOTED WITHIN THE RETURN SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 7240810 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [200719340, 200719497, 200719065, 20071171, 200711496, 200712723, 200712367] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING COMES OFF ON LOT#: 7240810. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE PRINT OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PRODUCT SMUDGES WHEN HE WIPES THE SYRINGES WITH ALCOHOL SWABS. FOUND DURING USE. THE CONSUMER ALSO STATED HE RE-USES THE SYRINGES. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE PRINT OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PRODUCT SMUDGES WHEN HE WIPES THE SYRINGES WITH ALCOHOL SWABS. FOUND DURING USE. THE CONSUMER ALSO STATED HE RE-USES THE SYRINGES. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE PRINT OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PRODUCT SMUDGES WHEN HE WIPES THE SYRINGES WITH ALCOHOL SWABS. FOUND DURING USE. THE CONSUMER ALSO STATED HE RE-USES THE SYRINGES. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499880 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 7240810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other