BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE (32G) (NEEDLE) N/A

    MDR report key: 2222357 · Received August 18, 2011

    Report

    Report Number
    9681821-2011-00028
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 27, 2011
    Manufacturer
    NOVO NORDISK A/S MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K062500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEEDLE CONCLUSION: BATCH HISTORY FROM FINAL QC-RELEASE EXAMINED. MICROSCOPICAL EXAMINATIONS PERFORMED. NEEDLES TESTED FOR RESISTANCE TO BREAKAGE. WE CAN CONFIRM THAT THE RETURNED UNSEALED NEEDLE TUBE IS BROKEN OFF AT THE NEEDLE HUB. NEEDLES TUBES ARE DELICATE, AND MUST NOT BE USED IF BENT OR OTHERWISE DAMAGED PRIOR TO USE. FURTHERMORE PLEASE NOTE THAT NEEDLES ARE FOR SINGLE-USE ONLY. DURING TEST IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE SEALED AND UNUSED NEEDLES, FROM THE SAME NEEDLE BOX AS THE NEEDLE INVOLVED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    NEEDLE BROKE OFF IN HER THIGH [NEEDLE ISSUE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. (B)(4). THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "NEEDLE WAS INSERTED INTO TISSUE" AND CONCERNS A (B)(6) FEMALE PATIENT TREATED USING NOVOFINE NEEDLES FROM AN UNKNOWN DATE TO AN UNKNOWN DATE DUE TO TYPE 1 DIABETES MELLITUS. PATIENT HEIGHT: (B)(6). MEDICAL HISTORY INCLUDES ASTHMA AND TREMOR. IN THE EVENING OF (B)(6), 2011, THE PATIENT ATTACHED A NW NOVOFINE 6 MM 32 G NEEDLE ON HER DEVICE. SHE DID A FUNCTION CHECK. AFTERWARDS SHE SELECTED 3 UNITS AND INJECTED IN HER LEFT THIGH WITH HER RIGHT HAND. PATIENT INJECTED INTO A SKIN FOLD THAT SHE BUILT UNTIL THE END OF INJECTION. NEEDLE WAS INSERTED INTO TISSUE IN A 90 DEGREE ANGLE. THE PATIENT IMMEDIATELY NOTICED AFTER INJECTION THAT THE NEEDLE HAD BROKEN OFF. SHE WENT TO THE HOSPITAL, BUT THE NEEDLE COULD NOT BE REMOVED AS IT WAS NOT VISIBLE, THOUGH THE PATIENT COULD FEEL IT WITH HER HANDS WHEN TOUCHING THE INJECTION SITE. NO FURTHER INVESTIGATION WAS DONE THEN. ON (B)(6), THE PATIENT WENT TO SEE HER SURGEON. THE SURGEON COULD NOT CLEARLY SEE THE NEEDLE ON THE RADIOGRAPH AND TOLD THE PATIENT TO WAIT AND SEE IF THE INJECTION SITE WOULD INFLAME. ON (B)(6), THE PATIENT WENT TO SEEN HER SURGEON AGAIN AS THE INJECTION SITE WAS INFLAMED WITH BLEEDING AND SANIES. ON (B)(6), THE NEEDLE WAS REMOVED SURGICALLY. AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN ON THE SURGERY SITE. SHE RECEIVED PARACETAMOL 500 ALMOST EVERY 2 HOURS FROM (B)(6). DUE TO THE PAIN, THE PATIENT HAD TO WALK ON CRUTCHES DURING THIS TIME. ABOUT 10 CM AROUND THE SCAR, THE PATIENT FEELS NUMBNESS. WITH THE USE OF A NEW BATCH, THE EVENT DID NOT REOCCUR. ANALYSIS REPLY: PRODUCT NOVOFINE 6MM 32 G TIP. LOT NO: 10E21S. NEEDLE CONCLUSION: BATCH HISTORY FROM FINAL QC-RELEASE EXAMINED. MICROSCOPICAL EXAMINATIONS PERFORMED. NEEDLES TESTED FOR RESISTANCE TO BREAKAGE. WE CAN CONFIRM THAT THE RETURNED UNSEALED NEEDLE TUBE IS BROKEN OFF AT THE NEEDLE HUB. NEEDLE TUBES ARE DELICATE, AND MUST NOT BE USED IF BENT OR OTHERWISE ACCIDENTALLY DAMAGED PRIOR TO USE. FURTHERMORE PLEASE NOTE THAT NEEDLES ARE FOR SINGLE-USE ONLY. DURING TESTING, IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE SEALED AND UNUSED NEEDLES, FROM THE SAME NEEDLE BOX AS THE NEEDLE INVOLVED IN THIS COMPLAINT. THIS CASE WAS RE-CLASSIFIED FROM NON-SERIOUS TO SERIOUS ON (B)(4), 2011 DUE TO FOLLOW-UP RECEIVED ADDING "INTERVENTION REQUIRED" SERIOUSNESS-CRITERIA TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE (32G) (NEEDLE) N/A NEEDLE FMI NOVO NORDISK A/S MEDICAL SYSTEMS NA 10E21S

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION| 100 U/ML| INJECTION| PROTAPHANE (INSULIN HUMAN), SUSPENSION FOR