BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 10823969 · Received November 11, 2020

    Report

    Report Number
    1213809-2020-00788
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    August 5, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903096573
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS AND ADDITIONAL INFORMATION: SITE LEGAL NAME (FDA): FRANKLIN LAKES, NJ. B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED BD¿ NEEDLE. D.2. MEDICAL DEVICE TYPE: FMI. D.2. COMMON DEVICE NAME: NEEDLE. D.2. MEDICAL DEVICE CATALOG #: UNKNOWN. D.3. MEDICAL DEVICE MANUFACTURER: FRANKLIN LAKES, NJ. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. G.1. MANUFACTURING LOCATION: FRANKLIN LAKES, NJ. G.5. PMA/510(K)#: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0072336. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ NEEDLE HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 0072336. IT WAS REPORTED THAT THERE WAS WHITE RESIDUE ON THE NEEDLES WHEN OPENED. VERBATIM: CALLER REPORTED THERE WAS A WHITE RESIDUE ON 2 NEEDLES WHEN PACKAGED WAS OPENED. NUMBER OF OCCURRENCES - 2. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT MANUFACTURED BY BD? YES, SAMPLE IS AVAILABLE FOR INVESTIGATION. RESOLUTION: CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CALLER REGARDING RETURNING SYRINGE/NEEDLE. CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER FOLLOW UP IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 0072336. IT WAS REPORTED THAT THERE WAS WHITE RESIDUE ON THE NEEDLES WHEN OPENED. VERBATIM: CALLER REPORTED THERE WAS A WHITE RESIDUE ON 2 NEEDLES WHEN PACKAGED WAS OPENED. NUMBER OF OCCURRENCES - 2. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT MANUFACTURED BY BD? - YES, SAMPLE IS AVAILABLE FOR INVESTIGATION. RESOLUTION - CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CALLER REGARDING RETURNING SYRINGE/NEEDLE. CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER FOLLOW UP IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 , BATCH NO: 0072336. IT WAS REPORTED THAT THERE WAS WHITE RESIDUE ON THE NEEDLES WHEN OPENED. VERBATIM: CALLER REPORTED THERE WAS A WHITE RESIDUE ON 2 NEEDLES WHEN PACKAGED WAS OPENED. NUMBER OF OCCURRENCES - 2. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT MANUFACTURED BY BD? - YES, SAMPLE IS AVAILABLE FOR INVESTIGATION. RESOLUTION - CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CALLER REGARDING RETURNING SYRINGE/NEEDLE. CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286062 UNSPECIFIED BD NEEDLE NEEDLE FMI BECTON DICKINSON 309657 UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR