BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 12089660 · Received June 29, 2021

    Report

    Report Number
    2243072-2021-01783
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 2, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: 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: NEEDLE 30X1/2 RB. D.2. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE . D.2. MEDICAL DEVICE CATALOG #: 305106. D.3. MEDICAL DEVICE MANUFACTURER: COLUMBUS. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. D.4. MEDICAL DEVICE LOT #: 8290968. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: COLUMBUS. G.5. PMA/510(K)#: K021475. H.4. DEVICE MANUFACTURE DATE: 2018-10-17.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 8290968. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB PENETRATED THROUGH SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE POKED THROUGH THE PLASTIC CAP CAUSING A NEEDLE STICK TO OFFICE STAFF. PER COMPLAINT DETAILS RECEIVED: ACCORDING TO THE MEDICAL SPECIALIST, THERE WAS AN INJECTION NEEDLE WHICH HAD POKED THROUGH THE PLASTIC CAP AND THE NEEDLE ENDED UP CAUSING A FINGER STICK TO THE OFFICE STAFF. THE INJECTION NEEDLE WAS CURLED BACKWARDS. REGENERON MEDICAL INFORMATION CONTACTED THE OFFICE STAFF AND SHE STATED THAT THE NEEDLE DID CAUSE A FINGER STICK RESULTING IN JUST A SMALL AMOUNT OF BLOOD. SHE DID NOT REQUEST REPLACEMENT AND NOTHING COULD BE RETRIEVED AS EVERYTHING WAS DISCARDED AND SHE DID NOT HAVE LOT NUMBER AND SERIAL NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB PENETRATED THROUGH SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE POKED THROUGH THE PLASTIC CAP CAUSING A NEEDLE STICK TO OFFICE STAFF. PER COMPLAINT DETAILS RECEIVED: ACCORDING TO THE MEDICAL SPECIALIST, THERE WAS AN INJECTION NEEDLE WHICH HAD POKED THROUGH THE PLASTIC CAP AND THE NEEDLE ENDED UP CAUSING A FINGER STICK TO THE OFFICE STAFF. THE INJECTION NEEDLE WAS CURLED BACKWARDS. REGENERON MEDICAL INFORMATION CONTACTED THE OFFICE STAFF AND SHE STATED THAT THE NEEDLE DID CAUSE A FINGER STICK RESULTING IN JUST A SMALL AMOUNT OF BLOOD. SHE DID NOT REQUEST REPLACEMENT AND NOTHING COULD BE RETRIEVED AS EVERYTHING WAS DISCARDED AND SHE DID NOT HAVE LOT NUMBER AND SERIAL NUMBER.

    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 PENETRATED THROUGH SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE POKED THROUGH THE PLASTIC CAP CAUSING A NEEDLE STICK TO OFFICE STAFF. PER COMPLAINT DETAILS RECEIVED: ACCORDING TO THE MEDICAL SPECIALIST, THERE WAS AN INJECTION NEEDLE WHICH HAD POKED THROUGH THE PLASTIC CAP AND THE NEEDLE ENDED UP CAUSING A FINGER STICK TO THE OFFICE STAFF. THE INJECTION NEEDLE WAS CURLED BACKWARDS. REGENERON MEDICAL INFORMATION CONTACTED THE OFFICE STAFF AND SHE STATED THAT THE NEEDLE DID CAUSE A FINGER STICK RESULTING IN JUST A SMALL AMOUNT OF BLOOD. SHE DID NOT REQUEST REPLACEMENT AND NOTHING COULD BE RETRIEVED AS EVERYTHING WAS DISCARDED AND SHE DID NOT HAVE LOT NUMBER AND SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985618 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8290968

    Patients

    Seq Age Sex Outcome Treatment
    1