FDA Adverse Event Injury Summary report: N

ARROW/COOK

MDR report key: 4060 · Received July 24, 1992

Report

Report Number: 4060
Event Type: Injury
Date Received: July 24, 1992
Date of Event: February 18, 1992
Manufacturer: ARROW/COOK
Product Code: GBP
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PHYSICIAN INSERTED ARROW TRIPLE LUMEN SUBCLAVIAN CATHETER. THE GUIDE WIRE BECAME BENT AND WAS DISPOSED OF. A REPLACEMENT GUIDE WIRE - COOK GUIDE WIRE WAS USED. BOTH CATHETER AND WIRE BECAME KNOTTED IN JUGULAR VEIN. PATIENT WENT TO OR FOR REMOVAL OF CATHETER AND WIRE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, GUIDEWIRE, OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARROW/COOK	ARROW TRIPLE LUMEN SUBCLAVIAN CATHETER/J TIP GUIDE WIRE	GBP	ARROW/COOK	NI	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Other