FDA Adverse Event
Injury
Summary report: N
BD INSYTE-W
MDR report key: 3093623
·
Received May 1, 2013
Report
- Report Number
- 2243072-2013-00043
- Event Type
- Injury
- Date Received
- May 1, 2013
- Date of Event
- March 6, 2013
- Report Date
- May 1, 2013
- Manufacturer
- BD
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE CATHETER WAS PLACED ON THE PT ON (B)(6) AND WHEN THEY WANTED TO REMOVE IT ON (B)(6), THE CATHETER BROKE OF ON THE HUB. AFTERWARDS THEY COULD LOCALIZE THE CATHETER WITH A MONITOR (RADIOGRAPHIC) AND REMOVE IT SURGICAL. THE CATHETER HAD MOVED FOR ABOUT 10CM. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188922 | BD INSYTE-W | 20G X 1.1MM | FOZ | BD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |