FDA Adverse Event
Malfunction
Summary report: N
ARROW CATH-LAB SHEATH INTRO SET:
MDR report key: 11723954
·
Received April 26, 2021
Report
- Report Number
- 9680794-2021-00164
- Event Type
- Malfunction
- Date Received
- April 26, 2021
- Date of Event
- January 20, 2021
- Report Date
- April 6, 2021
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- UDI-DI
- 00801902001849
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
QN# (B)(4). UPON INVESTIGATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE MALFUNCTION WAS NOT REPORTABLE; THUS THE INITIAL MDR, SUBMITTED ON 04/26/2021, SHOULD BE RETRACTED.
Additional Manufacturer Narrative · 1
QN#: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED "SHEATH UNABLE TO FLUSH" PRIOR TO PATIENT USE. A NEW DEVICE WAS OPENED FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624766 | ARROW CATH-LAB SHEATH INTRO SET: | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL INC. | IPN000136 | 14F18L0171 | 00801902001849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |