FDA Adverse Event Injury Summary report: N

INSULFON CATHETER

MDR report key: 905217 · Received August 3, 2007

Report

Report Number
905217
Event Type
Injury
Date Received
August 3, 2007
Date of Event
June 14, 2007
Report Date
August 3, 2007
Manufacturer
UNOMEDICAL, INC.
Product Code
DQO
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

PATIENT WITH SEVERE PROTEIN C DEFICIENCY, STATUS POST (S/P) PERINATAL STROKE, WHO HAS RESIDUAL DISABILITIES FROM THE STROKE AND REQUIRES LIFELONG ANTICOAGULATION TO PREVENT RECURRENCE. HER HOME ANTICOAGULATION IS SUPERVISED BY NURSE PRACTITIONER (NP) FOR THE ANTICOAGULATION SERVICE. THE DRUG IN USE FOR PROPHYLAXIS IS ENOXAPARIN ADMINISTERED SUBCUTANEOUSLY VIA INSUFLON CATHETER. NEW CATHETER WAS PLACED LAST WEEK BY MOTHER, WHO IS EXCEPTIONALLY COMPLIANT AND CAREFUL. LAST CATHETER PLACEMENT IN THE LEFT LOWER ABDOMEN RESULTED IN AN ABDOMINAL WALL HEMATOMA, FOR WHICH SHE WAS SEEN IN THE ED. ELECTED TO CONTINUE NECESSARY ANTICOAGULATION VIA OTHER SITES; THE BLEEDING WORSENED SUBSTANTIALLY REQUIRING ADMISSION TO THE ICP, AND RED CELL TRANSFUSION. THE DIAGNOSIS IS ABDOMINAL WALL (PROBABLY RECTUS SHEATH) BLEED, NO DOUBT RELATED IN PART TO THE INSUFLON PLACEMENT, AND IN PART TO THE REQUIREMENT FOR ANTICOAGULATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INSULFON CATHETER CATHETER, IV DQO UNOMEDICAL, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 7 YR Required Intervention