FDA Adverse Event
Malfunction
Summary report: N
NDEHP 2CLV YSTE MACR
MDR report key: 2152488
·
Received June 27, 2011
Report
- Report Number
- 9613251-2011-00138
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 14, 2011
- Manufacturer
- HOSPIRA LTD.
- Product Code
- FPA
- PMA / PMN Number
- K101677
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION BY GRAVITY. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET, THE TUBING SEPARATED FROM THE PROXIMAL END OF THE BACKCHECK VALVE. THE TUBING SET WAS REPLACED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NDEHP 2CLV YSTE MACR | 80FPA | FPA | HOSPIRA LTD. | NA | 012284W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |