FDA Adverse Event
Other
Summary report: N
BARDPORT: IMPLANTED PORT
MDR report key: 537877
·
Received July 12, 2004
Report
- Report Number
- 537877
- Event Type
- Other
- Date Received
- July 12, 2004
- Date of Event
- April 23, 2004
- Report Date
- June 25, 2004
- Manufacturer
- BARD ACCESS SYSTEM, INC.
- Product Code
- DRQ
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT ADMITTED FOR ANEMIA/METASTATIC WORK UP OF LEFT BREAST CANCER STAGE IIA. PAST MEDICAL HISTORY INCLUDE DIABETES MELLITUS, HYPERTENSION, HIGH CHOLESTEROL, FRACTURED SHOULDER. PT HAD CHEMOPORT PLACED AND WAS DISCHARGED HOME THE NEXT DAY. THE PT WAS READMITTED LATER WITH SEPSIS AND PNEUMONIA. CHEST X-RAYS REVEALED THAT THE CATHETER WAS DISSCONNECTED FROM THE CHEMOPORT AND MIGRATION TO PULMONARY ARTERY WAS CONFIRMED. ATTEMPTS BY INTERVENTIONAL RADIOLOGIST TO REMOVE CATHETER WAS UNSUCCESSFUL. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR REMOVAL OF CATHETER BY INVASIVE CARDIOLOGIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARDPORT: IMPLANTED PORT | CHEMOPORT | DRQ | BARD ACCESS SYSTEM, INC. | 0604550 | 22GN5787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | (2) DIALYSIS, 2004.| (1) CHEMOTHERAPY, 2004. |