FDA Adverse Event
Injury
Summary report: N
MICRO PUNCTURE KIT
MDR report key: 19894137
·
Received August 1, 2024
Report
- Report Number
- MW5157925
- Event Type
- Injury
- Date Received
- August 1, 2024
- Date of Event
- July 1, 2024
- Report Date
- July 29, 2024
- Manufacturer
- TELEFLEX LLC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WIRE TIP BROKE OFF THE WIRE INSIDE THE PATIENT WHILE TWO WIRES WERE IN THE BODY FROM TWO DIFFERENT LEFT SUBCLAVIAN ACCESS SITES. WIRE TIP WAS RETRIEVED BY THE INTERVENTIONAL RADIOLOGY TEAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383781 | MICRO PUNCTURE KIT | INTRODUCER, CATHETER | DYB | TELEFLEX LLC | IPN916062 | 73C2400407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |