BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 21X1-1/2 RB TW

    MDR report key: 8655269 · Received May 30, 2019

    Report

    Report Number
    1213809-2019-00581
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 14, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED FOR EVALUATION. THE PHOTOS DEPICTED AN ACTIVATED SAFETYGLIDE NEEDLE, WITH ITS SAFETY SHIELD EXTENDED. A DEFORMITY WITHIN THE HUB, NEAR THE TOP, AROUND THE CANNULA WAS OBSERVED IN ONE PHOTO. IT WAS NOT POSSIBLE TO DETERMINE WHAT THE DEFORMITY WAS FROM THE PHOTO PROVIDED. ONE PHOTO DEPICTED THE CANNULA EXTRACTED FROM THE NEEDLE ASSEMBLY. THE PRESUMED PREVIOUSLY OBSERVED DEFORMITY COULD BE SEEN AROUND THE LOWER PART OF THE CANNULA. IT APPEARED TO BE A CLEAR ATTACHED PIECE OF FOREIGN MATTER, LIQUID, OR ANOTHER SUBSTANCE. BASED ON THE PHOTO PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE THE NATURE OF THE REPORTED ISSUE AND WHAT WAS BEING DEPICTED. THREE (3) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. TWO (2) OF THE PHOTOS ARE SIMILAR SHOWING AN UNACTIVATED SAFETY GLIDE ASSEMBLY HELD VERTICALLY. THERE IS WHAT APPEARS TO BE AN AIR BUBBLE VISIBLE IN THE NEEDLE HUB PORTION OF THE ASSEMBLY. THE THIRD (3RD) PHOTO SHOWS THE SAFETY GLIDE ASSEMBLY AND NEEDLE WITH THE NEEDLE REMOVED FROM THE ASSEMBLY. IT APPEARS THAT THERE IS A CLEAR FOREIGN MATTER POSSIBLY EPOXY ON THE NEEDLE IN THE POSITION WHERE THE CUSTOMER REPORTED THE AIR BUBBLE. A SAMPLE WAS ATTEMPTED TO BE PROVIDED BY THE CUSTOMER; HOWEVER, IT WAS DESTROYED BY CUSTOMS ENROUTE. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER IT APPEARS THAT THE AIR BUBBLE REPORTED IS ACTUALLY EPOXY. BASED ON THE FACT THAT THE NEEDLE WAS ABLE TO BE REMOVED FROM THE NEEDLE HUB AND THE CLEAR APPEARANCE OF THE EPOXY IT APPEARS THAT THE NEEDLE HUB DID NOT HAVE SUFFICIENT EPOXY APPLIED WHICH RESULTED IN A CLEAR BUBBLE WHICH WAS OBSERVED BY THE CUSTOMER. BASED ON THE INVESTIGATION CONCLUSION BD ACKNOWLEDGES THAT THE SAMPLE IN THE PHOTO APPEARS TO NOT HAVE SUFFICIENT ADHESIVE WHICH APPEARED TO BE AN AIR BUBBLE. THE CUSTOMER DID NOT REPORT HOW MANY OCCURRENCES WERE OBSERVED; THEREFORE IT CANNOT BE DETERMINED IF THE ACCEPTABLE QUALITY LEVEL (AQL) OF ¿INSUFFICIENT ADHESIVE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE THREE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A HYPODERMIC SINGLE LUMEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN CHECKING THE PRODUCT, IT WAS FOUND THAT BUBBLES IN NEEDLE HUB AFTER OPENING THE UNIT PACKAGE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8086615. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-27. MEDICAL DEVICE LOT #: 8241639. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-29. MEDICAL DEVICE LOT #: 7121706. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2017-05-01. 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 FOREIGN MATTER OCCURRED WITH A HYPODERMIC SINGLE LUMEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN CHECKING THE PRODUCT, IT WAS FOUND THAT BUBBLES IN NEEDLE HUB AFTER OPENING THE UNIT PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446927 NEEDLE SFTYGLD 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other