BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOJECT HYPODERMIC SAFETY NEEDLE 22G,1 1/2

    MDR report key: 11440450 · Received March 8, 2021

    Report

    Report Number
    3014312726-2021-00001
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    December 30, 2020
    Report Date
    April 8, 2021
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    10884521544659
    PMA / PMN Number
    K123684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE ADDED IN THIS FOLLOW UP MDR SUBMITTED ON 8-APRIL-2021: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SOL-MILLENNIUM CONDUCTED INVESTIGATIONS ON ARCHIVED SAMPLES (LOT 18042612). SOL-MILLENNIUM PERFORMED VISUAL INSPECTION ON 15 SAMPLES, AND NO DEFECTS OR IMPERFECTION WERE OBSERVED. ADDITIONALLY, 5 SAMPLES WERE SUBJECTED TO THE STIFFNESS TEST PER STANDARD (ISO 9626), AND THE RESULT SHOWED THAT THE TESTED SAMPLES MET THE MAXIMUM DEFLECTION LIMIT. A RESISTANCE OF TUBING TO BREAKAGE TEST WAS ALSO CONDUCTED ON 5 SAMPLES AND THE RESULT SHOWS CONTINUED COMPLIANCE WITH ISO 1926. A CANNULA DETACHING FORCE TEST WAS CONDUCTED ON 5 SAMPLES ACCORDING TO ISO 7864:2016, AND THE RESULT SHOWED THAT THE FORCE REQUIRED TO DETACH THE CANNULA IS GREATER THAN 40 NEWTON. ADDITIONALLY, SOL-MILLENNIUM TESTED SAMPLES OF SOL-CARE SAFETY NEEDLE 22G X 1 ½" TAKEN FROM A DIFFERENT PRODUCTION LOT (02010037) USING SPECIAL INSPECTION LEVEL S-4 ACCORDING TO ISO 2859-1. STIFFNESS AND CANNULA DETACHING FORCE TESTS WERE REPEATED UTILIZING 80 SAMPLES FOR EACH TYPE OF TEST. ALL SAMPLES TESTED (TOTAL 160 PIECES) PASSED THE TESTS AND COMPLIED WITH ISO 9626:2016 AND WITH ISO 7864:2016. A REVIEW OF COMPLAINTS OF THE LAST TWO YEARS REVEALS THAT NO OTHER COMPLAINTS OF SAFETY NEEDLE 22G HAVE BEEN RECEIVED FOR DETACHED/LOOSE-CANNULA. CONCLUSION: OUR TESTING REVEALS THAT NO ANOMALIES WERE FOUND ON SAFETY NEEDLE 22G X 1 ½", REF 1182215, LOT 18042612. ALL TESTED SAMPLES (ARCHIVED SIMILAR LOT AND THE NEWER PRODUCTION LOT) PASSED THE REQUIREMENT OF THE APPLICABLE STANDARDS FOR NEEDLES (ISO 9626, ISO 7864). THE MONOJECT HYPODERMIC SAFETY NEEDLE 22G,1 1/2, MODEL# 1182215 PASSES ALL ISO TESTING AND FUNCTIONS AS DESIGNED. HEALTH HAZARD EVALUATION WAS CONDUCTED WITH INVESTIGATION RESULTS, AND THE OVERALL RISK WAS DEEMED ACCEPTABLE. THERE IS NO EVIDENCE OF AN ADVERSE COMPLAINT TREND. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. . NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A HEALTH HAZARD EVALUATION WAS COMPLETED BY SOL MILLENNIUM CLINICAL TEAM. PER THE EVALUATION, THE PATIENT REQUIRED HOSPITALIZATION IN ORDER TO EVACUATE THE HEMATOMA AND WOUND ABSCESS, WHICH WAS FURTHER PROLONGED DUE TO THE NEED FOR EXTENDED WOUND CARE. IT IS NOT POSSIBLE TO RULE OUT THAT THE ADVERSE EVENTS THAT OCCURRED AFTER THE EXTENSIVE WOUND EXPLORATION, WHICH HAD TO BE UNDERTAKEN DUE TO THE NEEDLE BREAKAGE, WERE THE OUTCOME OF THE INITIAL SURGERY. IT IS RECOGNIZED THAT HEMATOMA AND WOUND INFECTION ARE COMPLICATIONS THAT CAN OCCUR WITHIN 30 DAYS OF OPEN INGUINAL HERNIA REPAIR FOR AN INCARCERATED INGUINAL HERNIA WITHOUT ANY ADDITIONAL RISK FACTORS SUCH AS EXTENSIVE EXPLORATION AFTER SURGERY TO LOCATE AND REMOVE A DISCONNECTED NEEDLE CANNULA. THEREFORE, THE OBSERVED OUTCOME CANNOT BE COMPLETELY ATTRIBUTED TO THE DEVICE MALFUNCTION, I.E., IT IS POSSIBLE THAT THE HEMATOMA AND INFECTION WOULD HAVE OCCURRED EVEN WITHOUT THE UNPLANNED EXPLORATION TO REMOVE THE SEPARATED NEEDLE CANNULA FROM THE OPERATIVE AREA. THAT BEING SAID, FOR THE PURPOSE OF THIS ANALYSIS WE ASSESSED THE SEVERITY OF THE OUTCOME AS IF IT DID CONTRIBUTE TO THE POSTOPERATIVE COMPLICATION. BESIDES THE SEVERITY OF THE COMPLICATIONS (HEMATOMA FORMATION, INFECTION AND NEED FOR EXTENSIVE WOUND CARE WHICH LED TO THE S4 [SERIOUS INJURY ATTRIBUTION, BECAUSE THE PATIENT HAD AN UNPLANNED HOSPITALIZATION LESS THAN 30 DAYS AFTER THE EVENT WITH THE DEVICE, THIS EPISODE MEETS THE DEFINITION OF SERIOUS ADVERSE EVENT. HOWEVER, DUE TO THE FACT THAT THIS WAS A LOW PROBABILITY EVENT (1 IN OVER 5.5 MILLION USED DEVICES) THE OVERALL RISK WAS DEEMED ACCEPTABLE, AND AT THIS TIME PRODUCT REMOVAL IS NOT RECOMMENDED BASED ON THE HEALTH RISK. INVESTIGATION UPDATE: THE MANUFACTURING PARTNER CHECKED THE DHR OF THE LOT 18042612, THEY DID NOT FIND ANY ANOMALIES. ARCHIVE SAMPLES ANALYSIS IS ONGOING. MANUFACTURING PARTNER IS TESTING FOR CANNULA STIFFNESS TEST ACCORDING TO ISO 9626, RESISTANCE TO BREAK THE CANNULA ACCORDING TO ISO 9626, AND BOND BETWEEN NEEDLE HUB AND NEEDLE TUBE ACCORDING TO ISO 7864. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED BY 8-APRIL-2021.

    Description of Event or Problem · 1

    THE END USER DESCRIBED THAT ON (B)(6) 2020, IN THEIR SURGICAL DEPARTMENT A PATIENT WAS SCHEDULED FOR OPEN RIGHT INGUINAL HERNIA REPAIR FOR AN INCARCERATED RIGHT INGUINAL HERNIA. THE PATIENT HAD THE MONOJECT NEEDLE USED TO INJECT MEDICATION FOR POST SURGICAL NERVE BLOCK IN PATIENT'S RIGHT LOWER ABDOMEN. DURING INJECTING THE MEDICATION, THE NEEDLE BROKE OFF AT THE HUB AND REQUIRED EXTENSIVE EXPLORATION OF THE ABDOMEN TO LOCATE AND REMOVE THE BROKEN NEEDLE SEGMENT. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THEIR SURGICAL DEPARTMENT FOR WOUND INFECTION AT RIGHT LOWER ABDOMEN. HEMATOMA EVACUATION, INCISION AND DRAINAGE OF WOUND ABSCESS WERE PERFORMED AND THE WOUND VAC PLACEMENT WAS APPLIED. THE PATIENT REQUIRED OBSERVATION ADMISSION WITH EXTENDED STAY AND WAS PLACED AS INPATIENT DUE TO LEVEL OF CARE NEEDED. ON (B)(6) 2021. THE PATIENT WAS PLACED IN SWING BED CARE DUE TO EXTENDED WOUND CARE. ON (B)(6) 2021. THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH. CURRENTLY, THE PATIENT CONTINUES WITH HOME HEALTH CARE FOR WOUND CARE. THE PATIENT IS STILL UNDER CARE OF SURGEON AND HOME HEALTH. THE CUSTOMER FURTHER STATED THAT AN ESTIMATED DISCHARGE TIME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329899 MONOJECT HYPODERMIC SAFETY NEEDLE 22G,1 1/2 HYPODERMIC NEEDLE FMI SOL-MILLENNIUM MEDICAL INC. 1182215 18042612 10884521544659

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R