FDA Adverse Event
Malfunction
Summary report: N
3.5FR P.U.R. UMBIL CATH X10
MDR report key: 3170781
·
Received May 22, 2013
Report
- Report Number
- 1317749-2013-00160
- 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
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. MANSFIELD PRODUCT MONITORING REQUESTED ADDITIONAL INFORMATION ON (B)(4) 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. 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 |
|---|---|---|---|---|---|---|---|
| 226991 | 3.5FR P.U.R. UMBIL CATH X10 | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | 217003X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |