FDA Adverse Event
Malfunction
Summary report: N
WINGED INFUSION SET WITH INJECTION SITE
MDR report key: 1163449
·
Received September 10, 2008
Report
- Report Number
- 3006260740-2008-00110
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 9, 2008
- Report Date
- August 14, 2008
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- FMI
- PMA / PMN Number
- K863606
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT OF THE SUBCUTANEOUS LEAKAGE IS INCONCLUSIVE. DURING HYDRAULIC PRESSURIZATION NO LEAKS WAS OBSERVED EMANATING FROM THE WINGED INFUSION SET. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS, AND FUNCTIONAL TESTING SHOWED NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE PORT WAS NOT RETURNED FOR EVALUATION. PROPER DRESSING AND MONITORING OF THE ACCESS SITE, ALONG WITH CAREFUL NEEDLE SELECTION (SIZE AND LENGTH) CAN PREVENT THIS FAILURE. THE PRODUCT IFU PROVIDES NARRATIVE AND ILLUSTRATIVE DESCRIPTIONS FOR ACCESSING A BARD PORT. THIS MAY BE AN ACCESS TECHNIQUE ISSUE. A CHR IS NOT POSSIBLE. AS NO MANUFACTURING LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
A SUBCUTANEOUS LEAKAGE UPON DRUG ADMINISTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGED INFUSION SET WITH INJECTION SITE | FMI | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |