FDA Adverse Event
Malfunction
Summary report: N
ALARIS EXTENSION SET
MDR report key: 2190054
·
Received June 29, 2011
Report
- Report Number
- 9616066-2011-00357
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Report Date
- June 2, 2011
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K790108
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
RECEIVED A REPORT THAT EXTENSION SET TUBING WAS LEAKING AT THE CONNECTION TO THE SYRINGE. NOTE WITH RETURNED PRODUCT STATES "TUBING LEAKING AT CONNECTION TO SYRINGE. LEAKAGE CAUGHT AT BEGINNING OF INFUSION SO TUBING JUST CHANGED AND COMPLETED WITH THE NEW TUBING." ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO WAS PROVIDED. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS EXTENSION SET | FPA | CAREFUSION CORP | 30914 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS SYRINGE MODULE, SN UNK |