BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 25X1-1/2 RB NS

    MDR report key: 11838906 · Received May 17, 2021

    Report

    Report Number
    1911916-2021-00456
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 303018 AND LOT NUMBER 0252471. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25X1-1/2 RB NS NEEDLE CAP POPPED OFF CAUSING A POTENTIAL NEEDLE STICK INJURY. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303018 IT WAS REPORTED WHILE PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OF. VERBATIM: IT WAS REPORTED THAT WHILE PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF AND COULD CAUSED A POTENTIAL NEEDLESTICK. PER UNDATED LIST CAN YOU DESCRIBE IN DETAIL WHAT HAPPENED DURING THE REPORTED ISSUE? WHILE USING THE CONTROL SYRINGE THE SURGEON INJECTED LOCAL INTO THE PATIENT, HANDED IT BACK TO THE SCRUB TECH SO IT COULD BE REFILLED. AFTER RE-CAPPING THE HYPO IT WAS TWISTED TO ENSURE IT WAS SECURED TO THE CONTROL SYRINGE, TECH TURNED TOWARD THE BACK TABLE WHERE THE LOCAL WAS, WHILE REACHING TO REMOVE THE HYPO FROM THE SYRINGE THE CAP PROTECTING THE NEEDLE FELL OFF THE HYPO AND IT POKED THE TIP OF THE SCRUB TECHS FINGER. UPON INVESTIGATION IT WAS DISCOVERED THE CONTROL SYRINGE WAS ALLOWING THE HYPO TO BE SCREWED DOWN TOO FAR WHICH WAS CAUSING THE CAP TO BE DISLODGED FROM THE COLLAR LOCK ON THE NEEDLE. WERE THERE ANY ADVERSE EFFECTS/INJURY TO THE STAFF THAT REQUIRED THE STAFF TO RECEIVE ADDITIONAL MEDICAL CARE DUE TO THE NEEDLESTICK INCIDENT? O IF YES, WHAT WAS THE ADVERSE EFFECT/INJURY? SCRUB TECH HAD BLOOD DRAWN AND PATIENT WAS ALSO TESTED. O IF THERE WAS AN INJURY, PLEASE LIST: NEEDLE STICK WITH DIRTY HYPO TO FINGER. PREEXISTING MEDICAL CONDITIONS: NONE OTHER RELEVANT HISTORY: O WHAT TYPE OF TREATMENT WAS PROVIDED? (FOR EXAMPLE: WAS THIS AN HIV+ PATIENT AND DID THE SURGEON SEEK MEDICAL CARE?) N/A AT THIS TIME WAS ANY MEDICATION PROVIDED TO THE STAFF DUE TO THE NEEDLESTICK INCIDENT? IF YES, PLEASE PROVIDE THE FOLLOWING: NO O WHAT IS THE NAME OF THE MEDICATION? O IS THE MEDICATION OVER THE COUNTER OR PRESCRIBED BY A PHYSICIAN? O IS THE MEDICATION TAKEN ORALLY OR BY IV? HOW IS THE STAFF DOING NOW? FINE AT THIS TIME. PLEASE PROVIDE THE STAFF¿S AGE, GENDER, WEIGHT - PREFERS NOT TO ANSWER. JOB TITLE IS SURGICAL TECHNOLOGIST.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 NEEDLE 25X1-1/2 RB NS NEEDLE CAP POPPED OFF CAUSING A POTENTIAL NEEDLE STICK INJURY. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303018, BATCH NO: UNKNOWN. IT WAS REPORTED WHILE PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF. VERBATIM: IT WAS REPORTED THAT WHILE PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF AND COULD CAUSED A POTENTIAL NEEDLESTICK. PER UNDATED LIST: CAN YOU DESCRIBE IN DETAIL WHAT HAPPENED DURING THE REPORTED ISSUE? WHILE USING THE CONTROL SYRINGE THE SURGEON INJECTED LOCAL INTO THE PATIENT, HANDED IT BACK TO THE SCRUB TECH SO IT COULD BE REFILLED. AFTER RE-CAPPING THE HYPO IT WAS TWISTED TO ENSURE IT WAS SECURED TO THE CONTROL SYRINGE, TECH TURNED TOWARD THE BACK TABLE WHERE THE LOCAL WAS, WHILE REACHING TO REMOVE THE HYPO FROM THE SYRINGE THE CAP PROTECTING THE NEEDLE FELL OFF THE HYPO AND IT POKED THE TIP OF THE SCRUB TECHS FINGER. UPON INVESTIGATION, IT WAS DISCOVERED THE CONTROL SYRINGE WAS ALLOWING THE HYPO TO BE SCREWED DOWN TOO FAR WHICH WAS CAUSING THE CAP TO BE DISLODGED FROM THE COLLAR LOCK ON THE NEEDLE. WERE THERE ANY ADVERSE EFFECTS/INJURY TO THE STAFF THAT REQUIRED THE STAFF TO RECEIVE ADDITIONAL MEDICAL CARE DUE TO THE NEEDLESTICK INCIDENT? IF YES, WHAT WAS THE ADVERSE EFFECT/INJURY? SCRUB TECH HAD BLOOD DRAWN AND PATIENT WAS ALSO TESTED. IF THERE WAS AN INJURY, PLEASE LIST: NEEDLE STICK WITH DIRTY HYPO TO FINGER. PREEXISTING MEDICAL CONDITIONS: NONE. OTHER RELEVANT HISTORY: WHAT TYPE OF TREATMENT WAS PROVIDED? (FOR EXAMPLE: WAS THIS AN (B)(6) PATIENT AND DID THE SURGEON SEEK MEDICAL CARE?) N/A AT THIS TIME. WAS ANY MEDICATION PROVIDED TO THE STAFF DUE TO THE NEEDLESTICK INCIDENT? IF YES, PLEASE PROVIDE THE FOLLOWING: NO. WHAT IS THE NAME OF THE MEDICATION? IS THE MEDICATION OVER THE COUNTER OR PRESCRIBED BY A PHYSICIAN? IS THE MEDICATION TAKEN ORALLY OR BY IV? HOW IS THE STAFF DOING NOW? FINE AT THIS TIME. PLEASE PROVIDE THE STAFFS AGE, GENDER, WEIGHT - PREFERS NOT TO ANSWER. JOB TITLE IS SURGICAL TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728368 NEEDLE 25X1-1/2 RB NS HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0252471

    Patients

    Seq Age Sex Outcome Treatment
    1 Other