FDA Adverse Event Malfunction Summary report: N

PORT MRI GROSHONG 8 FR

MDR report key: 2852329 · Received November 19, 2012

Report

Report Number: 2852329
Event Type: Malfunction
Date Received: November 19, 2012
Date of Event: October 23, 2012
Report Date: November 19, 2012
Manufacturer: BARD ACCCESS SYSTEMS INC
Product Code: LJT
Product Problem: Yes
Report Source: User Facility report
Reporter Location: PA, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

FEMALE TREATED FOR COLON CA WITH CHEMOTHERAPY VIA LEFT PORT A CATH. CHEMOTHERAPY DISCONTINUED LAST MONTH AS THE PATIENT DID NOT WANT TO PROCEED WITH FURTHER TREATMENT. REMOVAL OF PORT A CATH SCHEDULED. DURING THE PROCEDURE TO REMOVE THE CATHETER, THE CHAMBER AND PLASTIC STABILIZER WAS REMOVED BUT THE CATHETER WAS NOTED TO BE DISCONNECTED FROM THE SYSTEM. ATTEMPTS MADE TO RETRIEVE BUT WERE UNSUCCESSFUL. PATIENT TAKEN TO IR FOR SAFE RETRIEVAL. SUCCESSFUL. PATIENT WAS DISCHARGED. NO FURTHER ISSUES. THIS PORT WAS IMPLANTED BY ANOTHER HEALTH CARE FACILITY.

Description of Event or Problem · 1

FEMALE TREATED FOR COLON CA WITH CHEMOTHERAPY VIA LEFT PORT A CATH. CHEMOTHERAPY DISCONTINUED LAST MONTH AS THE PATIENT DID NOT WANT TO PROCEED WITH FURTHER TREATMENT. REMOVAL OF PORT A CATH SCHEDULED. DURING THE PROCEDURE TO REMOVE THE CATHETER, THE CHAMBER AND PLASTIC STABILIZER WAS REMOVED BUT THE CATHETER WAS NOTED TO BE DISCONNECTED FROM THE SYSTEM. ATTEMPTS MADE TO RETRIEVE BUT WERE UNSUCCESSFUL. PATIENT TAKEN TO OR FOR SAFE RETRIEVAL. SUCCESSFUL. PATIENT WAS DISCHARGED. NO FURTHER ISSUES. THIS PORT WAS IMPLANTED BY ANOTHER HEALTH CARE FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PORT MRI GROSHONG 8 FR	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR	LJT	BARD ACCCESS SYSTEMS INC	*	REV10789

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR			NO OTHER THERAPIES