FDA Adverse Event
Other
Summary report: N
DAR
MDR report key: 718637
·
Received May 19, 2006
Report
- Report Number
- 2936999-2006-00568
- Event Type
- Other
- Date Received
- May 19, 2006
- Report Date
- May 5, 2006
- Manufacturer
- *
- Product Code
- BZQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE WAS RETURNED TO THE MANUFACTURE. INVESTIGATION OF THE DEVICE HISTORY RECORDS AND COMPLAINT RECORDS FOR THIS PRODUCT NUMBER FROM 1998 TO DATE REVEALED THERE WERE NO NONCONFORMITIES DURING PRODUCTION OR SIMILAR COMPLAINTS.
Description of Event or Problem · 1
A DAR 15M CATHETER MOUNT FLEXIBLE ADAPTER WOULD NOT NOT FIT AN UNSPECIFIED CONNECTION DURING PATIENT USE. IT WAS REPORTED THE PATIENT WAS A CHILD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAR | CATHETER MOUNT FLEXIBLE ADAPTER | BZQ | * | 15M/15F 25/CA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |