FDA Adverse Event Malfunction Summary report: N

GUIDEWIRE

MDR report key: 21063 · Received March 7, 1995

Report

Report Number: 21063
Event Type: Malfunction
Date Received: March 7, 1995
Date of Event: May 26, 1994
Report Date: February 17, 1995
Manufacturer: BARD INTERVENTIONAL PRODUCTS (C.R. BARD INC.)
Product Code: MKI
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON 5/26/1994, A DOCTOR WAS REMOVING THE GUIDEWIRE IN OUR GI UNIT AND NOTICED THAT THE TIP HAD BROKEN OFF. THE TIP OF THE GUIDEWIRE WAS THEN RETRIEVED WITH AN ENDOSCOPE AND GRABBER. THERE WAS NO INJURY TO THE PATIENT. THE WIRE WAS RETURNED TO THE MANUFACTURER.INVALID 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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	GUIDEWIRE		MKI	BARD INTERVENTIONAL PRODUCTS (C.R. BARD INC.)	AE3600150

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other