BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 30

    MDR report key: 276854 · Received May 10, 2000

    Report

    Report Number
    9681821-2000-00009
    Event Type
    Injury
    Date Received
    May 10, 2000
    Date of Event
    March 22, 2000
    Report Date
    April 25, 2000
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BROKEN NEEDLE IN ABDOMEN (NEEDLE INJURY). CASE DESCRIPTION: A BECTON DICKINSON REP REPORTED THAT A PT HAD AN INSULIN NEEDLE BREAK OFF IN ABDOMEN, WHICH REQUIRED SURGICAL REMOVAL. THE REP STATED THAT WHEN BECTON DICKINSON RECEIVED THE NEEDLE HUB FROM THE PT, THE CO DETERMINED THAT IT WAS NOT THEIR PRODUCT BECAUSE IT HAD A WHITE PLASTIC HUB AND THEIR NEEDLES HAVE A CLEAR PLASTIC HUB. IN DIRECT CONTACT WITH THE PT, PT REPORTED THAT ON 22-MAR-2000 THE NEEDLE BROKE OFF IN ABDOMEN AND SHORTLY AFTERWARD PT WENT TO A CLINIC TO HAVE THE NEEDLE REMOVED. THE SAME DAY A FLUOROSCOPY WAS PERFORMED TO LOCATE THE NEEDLE, WHICH WAS THEN SURGICALLY REMOVED FROM THE SUBCUTANEOUS FAT IN PT ABDOMEN. A NURSE AT THE CLINIC STATED THAT THE PROCEDURE WAS DONE ON AN OUTPATIENT BASIS AND THE PT WAS NOT HOSPITALIZED. THE PT STATED THAT ALTHOUGH A PRESCRIPTION (MEDICATION NOT SPECIFIED) WAS WRITTEN, PT DID NOT TAKE ANY ANTIBIOTICS AFTER THE SURGERY BECAUSE PT DOES NOT HAVE INSURANCE. PT REPORTED THAT THEY HAVE SINCE SWITCHED TO USING CONVENTIONAL SYRINGES. THE PT STATED THAT THEY DO NOT REUSE THE NEEDLES.

    Description of Event or Problem · 1

    BROKEN NEEDLE IN ABDOMEN [NEEDLE INJURY] CASE DESCRIPTION: A BECTON DICKINSON REP REPORTED THAT A PT HAD A INSULIN BREAK OFF IN HER ABDOMEN, WHICH REQUIRED SURGICAL REMOVAL. THE REP STATED THAT WHEN BECTON DICKINSON RECEIVED THE NEEDLE HUB FROM THE PT, THE CO DETERMINED THAT IT WAS NOT THEIR PRODUCT BECAUSE IT HAD A WHITE PLASTIC HUB AND THEIR NEEDLES HAVE A CLEAR PLASTIC HUB. IN DIRECT CONTACT WITH THE PT, PT REPORTED THAT ON 3/22/2000 THE NEEDLE BROKE OFF IN HER ABDOMEN AND SHORTLY AFTERWARD PT WENT TO A CLINIC TO HAVE THE NEEDLE REMOVED. THE SAME DAY A FLUOROSCOPY WAS PERFORMED TO LOCATE THE NEEDLE, WHICH WAS THEN SURGICALLY REMOVED FROM THE SUBCUTANEOUS FAT IN ABDOMEN. A NURSE AT THE CLINIC STATED THAT THE PROCEDURE WAS DONE ON AN OUTPATIENT BASIS AND THE PT WAS NOT HOSPITALIZED. THE PT STATED THAT ALTHOUGH A PRESCRIPTION (MEDICATION NOT SPECIFIED) WAS WRITTEN, PT DID NOT TAKE ANY ANTIBIOTICS AFTER THE SURGERY BECAUSE PT DOES NOT HAVE INSURANCE. PT REPORTED THAT PT HAS SINCE SWITCHED TO USING CONVENTIONAL SYRINGES. PT STATED THAT PT DOES NOT REUSE THE NEEDLES. FOLLOW-UP INFO ON 5/8/2000: IN A POSTOPERATIVE REPORT, THE PHYSICIAN STATED THAT THE PT PRESENTED WITH A BROKEN INSULIN NEEDLE IN RIGHT, LOWER QUADRANT ABDOMINAL WALL. PT REQUESTED THAT THE NEEDLE BE REMOVED SINCE IT WAS CAUSING PAIN. THE PHYSICIAN DISCUSSED THE RISKS OF REMOVING THE NEEDLE, I.E., RISK OF INFECTION, BLEEDING, HEALING PROBLEMS, OR NOT FINDING THE NEEDLE, THEN PROCEEDED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 30 NEEDLE FMI NOVO NORDISK A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention 1. NOVOPEN 1.5 (INSULIN DELIVERY DEVICE) NA UNK TO| 3. PROZAC (FLUOXETINE HYDROCHLORIDE) UNK TO UNK.| UNK 2. HUMALOG (INSULIN LISPRO) UNK TO UNK,