FDA Adverse Event Malfunction Summary report: N

FAST-CATH HEMOSTATIS INTRODUCER

MDR report key: 3895 · Received July 14, 1992

Report

Report Number: 3895
Event Type: Malfunction
Date Received: July 14, 1992
Report Date: July 1, 1992
Manufacturer: DIAG CORPORATION
Product Code: EYT
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

DIAG SHEATH 6F NOTED AT SIDE PORT WHEN PLACED IN PATIENT. SHEATH CHANGED OUT IN CATH LAB WITH NO APPARENT INJURY TO PATIENT. MANUFACTURER REP. CALLED-LOT REPLACED. ON PREVIOUS DAY ADDITIONAL SHEATH FROM SAME LOT LEAKED. PATIENT REQUIRED BLOOD TRANSFUSION PRIOR TO PROCEEDING WITH PROCEDUREINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID 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	FAST-CATH HEMOSTATIS INTRODUCER		EYT	DIAG CORPORATION	406104

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other