FDA Adverse Event Death Summary report: N

EXTERNAL DRAINAGE COLLECTION KIT

MDR report key: 6307 · Received August 16, 1993

Report

Report Number
6307
Event Type
Death
Date Received
August 16, 1993
Date of Event
July 2, 1993
Report Date
July 17, 1993
Manufacturer
CODMAN & SHURTLEFF, INC.
Product Code
FCN
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT ADMITTED 6/29/93 WITH GRADE IV SUBARACHNOID HEMORRHAGE. EMERGENCY VENTRICULOSTOMY PERFORMED WITH VENTRICULAR CATHETER. ON 7/2/93, PATIENT PULLED OUT THE EXTRACRANIAL PORTION OF THE SHUNT TUBE WHICH BROKE AND PART OF IT WAS LEFT IN THE PATIENT'S LEFT FRONTAL HORN. A CT SCAN WAS PERFORMED SHOWING NO ADVERSE CONSEQUENCE RELATIVE TO THE INCIDENT. SEVERAL DAYS FOLLOWING THE INCIDENT, THE PATIENT WAS DETERMINED BRAIN DEAD, CODED AND EXPIRED. THE PATIENT'S EXPIRATION WAS NOT RELATIVE TO THE PATIENT PULLING OUT THE CATHETERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EXTERNAL DRAINAGE COLLECTION KIT Implant FCN CODMAN & SHURTLEFF, INC. 82-1700

Patients

Seq Age Sex Outcome Treatment
1 52 YR Death