FDA Adverse Event
Malfunction
Summary report: N
ANGIOCATH N AUTOGUARD
MDR report key: 5105006
·
Received September 21, 2015
Report
- Report Number
- MW5056503
- Event Type
- Malfunction
- Date Received
- September 21, 2015
- Date of Event
- September 21, 2015
- Report Date
- September 21, 2015
- Manufacturer
- BD
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- 2
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A BD ANGIOCATH-N AUTOGUARD 24 GAUGE X 0.56 INCH BROKE OFF AT THE HUB. LOT NUMBERS INCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623516 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 3289840 | ||
| 623517 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 5002915 | ||
| 623518 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 3106688 | ||
| 623519 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 5063827 | ||
| 623520 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 4203557 | ||
| 623521 | ANGIOCATH N AUTOGUARD | ANGIOCATH | FOZ | BD | 4059581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |