FDA Adverse Event
Malfunction
Summary report: N
KIT, PTFE, INTRODUCER KIT 1-PACK, 6FR
MDR report key: 13485720
·
Received February 8, 2022
Report
- Report Number
- 2183787-2022-00003
- Event Type
- Malfunction
- Date Received
- February 8, 2022
- Date of Event
- January 10, 2022
- Report Date
- January 17, 2022
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DYB
- UDI-DI
- 30821329000318
- PMA / PMN Number
- K000824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DURING PREPARATION AND BEFORE OPENING OF THE PACKAGING, A SMALL, BLACK FOREIGN OBJECT CAN BE SEEN WITHIN THE SEALED PACKING OF THE 7087 6F INTRODUCER, ATTACHED TO THE 'J' OF THE INTRODUCER WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1850305 | KIT, PTFE, INTRODUCER KIT 1-PACK, 6FR | INTRODUCER, CATHETER | DYB | GREATBATCH MEDICAL | 1000558-001 | GB6601852 | 30821329000318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |