FDA Adverse Event
Malfunction
Summary report: N
MINIVOLUME EXTENSION SET
MDR report key: 1240647
·
Received November 25, 2008
Report
- Report Number
- 6000001-2007-02128
- Event Type
- Malfunction
- Date Received
- November 25, 2008
- Date of Event
- November 17, 2006
- Report Date
- January 5, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- 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
COMPLAINT RECEIVED FROM USER FACILITY REPORT NUMBER 363305000-2006-8008. REPORT STATES ¿PICC LINE WITH 3 EXTENSION PORTS. WHEN NURSE TRIED TO USE ONE OF THE THREE PORTS, SHE NOTICED THE PORT WAS LEAKING. THIS LEAKING PORT HAD CRACKED AND BROKE OFF.¿ THRERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIVOLUME EXTENSION SET | EXTENSION SETS | FPA | BAXTER HEALTHCARE CORPORATION | NA | GR245829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |