BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8387560 · Received March 4, 2019

    Report

    Report Number
    1911916-2019-00236
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE TIP OF THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO: 305106. BATCH NO: 7264532. IT WAS REPORTED THAT PHYSICIAN DISCOVERED A PIECE OF FUZZ ON THE TIP OF THE NEEDLE. PER COMPLAINT DESCRIPTION: ON (B)(6) 2018, REGENERON QA RECEIVED THE FOLLOWING PRODUCT COMPLAINT: THE REPORTER STATED THE PHYSICIAN STATED THERE WAS A LITTLE PIECE OF FUZZ ON THE TIP OF THE INJECTION (30 GAUGE) NEEDLE SO THE EYLEA WAS NOT ADMINISTERED TO THE PATIENT. WHEN WAS THE FOREIGN MATTER NOTICED: WHILE PRIMING THE INJECTION NEEDLE CAN YOU DESCRIBE THE FOREIGN MATTER IN TERMS OF SHAPE/COLOR/SIZE? LITTLE PIECE OF FUZZ NOTED ON THE METAL SHAFT OF THE NEEDLE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE TIP OF THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO: 305106 BATCH NO: 7264532. IT WAS REPORTED THAT PHYSICIAN DISCOVERED A PIECE OF FUZZ ON THE TIP OF THE NEEDLE. PER COMPLAINT DESCRIPTION: ON DECEMBER 3, 2018, REGENERON QA RECEIVED THE FOLLOWING PRODUCT COMPLAINT: THE REPORTER STATED THE PHYSICIAN STATED THERE WAS A LITTLE PIECE OF FUZZ ON THE TIP OF THE INJECTION (30 GAUGE) NEEDLE SO THE EYLEA WAS NOT ADMINISTERED TO THE PATIENT. WHEN WAS THE FOREIGN MATTER NOTICED: WHILE PRIMING THE INJECTION NEEDLE CAN YOU DESCRIBE THE FOREIGN MATTER IN TERMS OF SHAPE/COLOR/SIZE? LITTLE PIECE OF FUZZ NOTED ON THE METAL SHAFT OF THE NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182160 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7264532 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other