BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 10311744 · Received July 22, 2020

    Report

    Report Number
    1213809-2020-00474
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 2, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION? YES. D.10. RETURNED TO MANUFACTURER ON:(B)(6)2020. H.6. INVESTIGATION: NUMEROUS PHOTOS AND TWENTY-TWO PHYSICAL SAMPLES WERE RECEIVED. THE SAMPLES WERE SEALED 1ML SAFETYGLIDE COMBO PRODUCT, CONFIRMED TO BE FROM BATCH #9177763 (305903). THE SAMPLE APPEARED TO REPRESENT THE ATTACHED PHOTOS AND WERE VISUALLY EVALUATED. LOOSE BLACK FOREIGN MATTER PARTICULATE WAS OBSERVED PRESENT IN MOST OF THE PACKAGES ON THE INSIDE. SOME OF THE PACKAGES WERE OBSERVED TO HAVE FOREIGN MATTER STREAKS ON THE INSIDE OF THE BOTTOM WEB IN THE SYRINGE¿S POCKET. IT WAS ALSO PRESENT AS SMUDGED PARTICULATE ON THE INSIDE OF THE NEEDLE POCKET. SOME OF THE PACKAGES¿ COMPONENTS HAD THE FM RESIDUE PRESENT ON THEIR SURFACE, INCLUDING THE THUMB PRESS AND NEEDLE SHIELD. THE DARK STREAKS OF MATERIAL IS MOST LIKELY INK MIXED WITH SILICONE. THE SPOTS OF MATERIAL ARE MOST LIKELY METALLIC IN NATURE. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON 27 BD SAFETYGLIDE¿ INSULIN SYRINGES WITH ATTACHED NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ACCORDING TO THE PROCUREMENT FEEDBACK FROM THE EQUIPMENT DEPARTMENT, THE THERE WAS BLACK FOREIGN MATTER IN THE SYRINGE PACKAGE, WHICH WAS NOT USED YET."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980580 (SYRINGE). PMA / 510(K)#: K951254 (NEEDLE). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON 27 BD SAFETYGLIDE¿ INSULIN SYRINGES WITH ATTACHED NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ACCORDING TO THE PROCUREMENT FEEDBACK FROM THE EQUIPMENT DEPARTMENT, THE THERE WAS BLACK FOREIGN MATTER IN THE SYRINGE PACKAGE, WHICH WAS NOT USED YET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776047 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305903 9177763 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other