FDA Adverse Event
Malfunction
Summary report: N
RA CATH SET: 22 GA X 1-3/8
MDR report key: 1230375
·
Received November 7, 2008
Report
- Report Number
- 9680794-2008-00021
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 24, 2008
- Report Date
- November 7, 2008
- Manufacturer
- ARROW INTERNACIONAL INC
- Product Code
- DQO
- PMA / PMN Number
- K810675
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CLINICIAN THAT WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT, THE TIP OF THE CATHETER WAS MISSING. NO FURTHER DETAILS WILL BE RELEASED FROM RISK MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RA CATH SET: 22 GA X 1-3/8 | RADIAL ARTERY PRODUCTS | DQO | ARROW INTERNACIONAL INC | CF8061040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |