FDA Adverse Event
Malfunction
Summary report: N
JEHLE CATH 4-HEAD STERILE 5/BX
MDR report key: 1026249
·
Received April 8, 2008
Report
- Report Number
- 1044475-2008-00005
- Event Type
- Malfunction
- Date Received
- April 8, 2008
- Date of Event
- March 15, 2008
- Report Date
- March 17, 2008
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS RECEIVED ON 03/24/2008 AND IS UNDER EVALUATION. UPON COMPLETION OF THE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT A CATHETER WAS OBSTRUCTED DURING HEART SURGERY, BUT THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JEHLE CATH 4-HEAD STERILE 5/BX | JEHLE CATH | DYB | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |