FDA Adverse Event Injury Summary report: N

CUFFED TRUE MURPHY TIP WITH EYE

MDR report key: 4171 · Received July 1, 1992

Report

Report Number: 4171
Event Type: Injury
Date Received: July 1, 1992
Date of Event: January 28, 1992
Report Date: February 3, 1992
Manufacturer: MALLINCKRODT CRITICAL CARE
Product Code: BSK
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT ADMITTED TO EMERGENCY DEPARTMENT IN RESPIRATORY DISTRESS. NASAL-TRACHEAL INTUBATION ATTEMPTED. ATIENT DEVELOPED EPISAXIS AND REQUIRED CONSULTATION AND TREATMENT BY ENT SPECIALIST TO CONTROL BLEEDING. PATIENT IS HYPERTENSIVE AND ON ANTICOAGULANTS.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 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: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CUFFED TRUE MURPHY TIP WITH EYE	NASAL - TRACHEAL TUBE - ENDOTROL	BSK	MALLINCKRODT CRITICAL CARE	86351	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention