FDA Adverse Event Injury Summary report: N

PHARMACIA

MDR report key: 4130 · Received July 20, 1992

Report

Report Number
4130
Event Type
Injury
Date Received
July 20, 1992
Date of Event
February 19, 1992
Report Date
March 2, 1992
Manufacturer
PHARMACIA
Product Code
LKG
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

SUBCUTANEOUS INFUSION PORT INSERTED INTO THE RIGHT SUBCLAVIAN VEIN SEPTEMBER, 1991. PORT INFECTED AND PATIENT TAKEN TO OR FOR REMOVAL FEBRUARY 19, 1992. PATIENT GIVEN IV SEDATION. FLUOROSCOPY DONE TO VISUALIZE CAHTETER PRIOR TO REMOVAL. CATHETER VISUALIZED IN RIGHT ATRIUM. DYE INJECTED TO SEE HOW MUCH OF CATHETER LEFT IN SUBCLAVIAN VEIN. PORT REMAINED IN PLACE BUT THE ENTIRE CATHETER HAD SHEARED OFF AND WAS CONTAINED IN THE RIGHT ATRIUM. PATIENT TAKEN TO RADIOLOGY FOR REMOVAL. RADIOLOGY USED A SNARE TO SUCCESSFULLY RETREIVE THE CATHETER FROM THE RIGHT ATRIUM. MFG. WAS CALLED AFTER THE EVENT. DEVICE HAS BEEN KEPT IN THE RISK MANAGEMENT OFFICEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHARMACIA Implant PORTACATH LKG PHARMACIA 21-4003 18071

Patients

Seq Age Sex Outcome Treatment
1 52 YR Required Intervention