BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 25X1-1/2 RB NS

    MDR report key: 11845991 · Received May 18, 2021

    Report

    Report Number
    1911916-2021-00458
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 25, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-21. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE NEEDLE CAP POPPED OFF OF THE SYRINGE WHICH RESULTED IN A NEEDLE STICK INJURY TO THE TECHNICIAN. TO AID IN THE INVESTIGATION, TWO SAMPLES AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THEY ARE 10ML SYRINGES NOT PRODUCED BY THIS SITE. THERE IS NO NEEDLE ASSEMBLY SAMPLE. ONE PHOTO SHOWS ONE SYRINGE, ANOTHER PHOTO SHOWS FOUR SYRINGES AND THE THIRD PHOTO SHOWS THREE SYRINGES. NONE OF THE SYRINGES SHOWN IN THE THREE PHOTOS HAVE A NEEDLE ASSEMBLY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303018, LOT NUMBER 0252471. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INFORMATION PROVIDED THIS IS OFF LABEL USE; THIS PRODUCT IS SINGLE USE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS OF A NEEDLE ASSEMBLY THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25X1-1/2 RB NS CAP CAME OFF AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 303018, BATCH NO. 0252471. IT WAS REPORTED THAT THE NEEDLE CAP POPPED OFF OF THE SYRINGE WHICH RESULTED IN A NEEDLE STICK INJURY TO THE TECHNICIAN. VERBATIM: WHEN PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF. WHEN PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF AND COULD CAUSE A POTENTIAL NEEDLESTICK AND IT DID CAUSE A NEEDLESTICK. 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 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 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 STAFF¿S AGE, GENDER, WEIGHT - PREFERS NOT TO ANSWER JOB TITLE IS SURGICAL TECHNOLOGIST

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 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. INVESTIGATION CONCLUSION: THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. IT COULD BE POSSIBLE THE CUSTOMER WAS NOT USING THE PRODUCT AS INTENDED; THESE PRODUCTS ARE SINGLE USE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 25X1-1/2 RB NS CAP CAME OFF AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 303018 BATCH NO. 0252471. IT WAS REPORTED THAT THE NEEDLE CAP POPPED OFF OF THE SYRINGE WHICH RESULTED IN A NEEDLE STICK INJURY TO THE TECHNICIAN. VERBATIM: WHEN PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF. WHEN PLACING THE HYPO NEEDLE WITH CAP ON THE CONTROL SYRINGE, THE NEEDLE CAP POPS OFF AND COULD CAUSE A POTENTIAL NEEDLESTICK AND IT DID CAUSE A NEEDLESTICK. 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 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. 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 STAFF¿S AGE, GENDER, WEIGHT - PREFERS NOT TO ANSWER. JOB TITLE IS SURGICAL TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741784 NEEDLE 25X1-1/2 RB NS NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0252471

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention