FDA Adverse Event
Malfunction
Summary report: N
CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR
MDR report key: 1932602
·
Received December 19, 2010
Report
- Report Number
- 6000001-2010-06008
- Event Type
- Malfunction
- Date Received
- December 19, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 18, 2010
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A DELIVERY TEST WAS PERFORMED ON THE RETURNED SAMPLE WITH NO ABNORMALITY OBSERVED. BATCH REVIEW WAS PERFORMED WITH NO ABNORMALITY OBSERVED. BASED ON THE EVALUATION RESULT ON THE RETURNED SAMPLE, THE REPORTED COMPLAINT CANNOT BE CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK SECONDARY MEDICATION SET THAT WAS USED WITH AN UNKNOWN ANTIBIOTIC AND WOULD NOT FLOW. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE TUBING WAS CHANGED OUT, AND THE TUBING RAN FINE WITH NO PROBLEMS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK ANTIBIOTIC |