FDA Adverse Event
Malfunction
Summary report: N
INTELINK I.V. CATH. EXT SET/MALE LUER SLIP ADAPT.
MDR report key: 1230531
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88686
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- June 28, 2007
- Report Date
- June 29, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K925126
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, SHOULD THE REPORTED DEVICE BE RETURNED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
INTERNATIONAL COMPLAINT RECEIVED FROM ANOTHER COUNTRY. CUSTOMER REPORTS "OFF/TUBING-CONNECTOR" DURING PATIENT USE. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELINK I.V. CATH. EXT SET/MALE LUER SLIP ADAPT. | 80FPA | FPA | BAXTER HEALTHCARE CORPORATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |