BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8848167 · Received July 31, 2019

    Report

    Report Number
    2243072-2019-01553
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.1. MEDICAL DEVICE BRAND NAME: BD PRECISIONGLIDE¿ NEEDLE. D.2. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. D.2. MEDICAL DEVICE CATALOG #: 305106. D.3. MEDICAL DEVICE MANUFACTURER: COLUMBUS. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: COLUMBUS. G.5. PMA/510(K)#: K021475.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTO OR SAMPLES WERE PROVIDED FOR THE INVESTIGATION OF THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE IS CLOGGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305106 BATCH NO. UNKNOWN. IT WAS REPORTED THE NEEDLE IS CLOGGED. MULTIPLE RETINA SURGEONS IN MY PRACTICE HAVE BEEN NOTICING A RECENT CHANGE IN THE QUALITY OF THE 30 GAUGE NEEDLES. WHEN WE GO TO INJECT THROUGH THEM WE NOTICE THEY ARE CLOGGED AND DO NOT WORK. IF WE CHANGE OVER TO NEW NEEDLE THE INJECTION GOES WITHOUT ISSUE. THIS HAS BEEN NOTICED AT MULTIPLE SITES THROUGHOUT (B)(6) WITH DIFFERENT MEDICATIONS AND SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ NEEDLE IS CLOGGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THE NEEDLE IS CLOGGED. MULTIPLE RETINA SURGEONS IN MY PRACTICE HAVE BEEN NOTICING A RECENT CHANGE IN THE QUALITY OF THE 30 GAUGE NEEDLES. WHEN WE GO TO INJECT THROUGH THEM WE NOTICE THEY ARE CLOGGED AND DO NOT WORK. IF WE CHANGE OVER TO NEW NEEDLE THE INJECTION GOES WITHOUT ISSUE. THIS HAS BEEN NOTICED AT MULTIPLE SITES THROUGHOUT NORTHERN CALIFORNIA WITH DIFFERENT MEDICATIONS AND SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ NEEDLE IS CLOGGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN , BATCH NO. UNKNOWN. IT WAS REPORTED THE NEEDLE IS CLOGGED. MULTIPLE RETINA SURGEONS IN MY PRACTICE HAVE BEEN NOTICING A RECENT CHANGE IN THE QUALITY OF THE 30 GAUGE NEEDLES. WHEN WE GO TO INJECT THROUGH THEM WE NOTICE THEY ARE CLOGGED AND DO NOT WORK. IF WE CHANGE OVER TO NEW NEEDLE THE INJECTION GOES WITHOUT ISSUE. THIS HAS BEEN NOTICED AT MULTIPLE SITES THROUGHOUT NORTHERN CALIFORNIA WITH DIFFERENT MEDICATIONS AND SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638604 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other