FDA Adverse Event
Malfunction
Summary report: N
3.5FR P.U.R. UMBIL CATH X10
MDR report key: 3170758
·
Received May 22, 2013
Report
- Report Number
- 1317749-2013-00157
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 22, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 05/21/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING HAS REQUESTED ADDITIONAL INFORMATION ON 04/30/2013, 05/06/2013, 05/09/2013, 05/13/2013, AND 05/17/2013. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE DEVICE PIERCED AT THE DISTAL LEVEL, UNDER THE CONNECTION, WHEN THE NURSE INJECTED ANTIBIOTICS INTO THE BABY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226418 | 3.5FR P.U.R. UMBIL CATH X10 | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | 217003X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |