FDA Adverse Event
Malfunction
Summary report: N
TERUMO AVF SET
MDR report key: 43958
·
Received October 18, 1996
Report
- Report Number
- 1118880-1996-00018
- Event Type
- Malfunction
- Date Received
- October 18, 1996
- Report Date
- September 17, 1996
- Manufacturer
- TERUMO MEDICAL, CORP. EAST
- Product Code
- FIE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LEAKING AROUND THE NEEDLE ON MORE THAN ONE OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO AVF SET | AV FISTULA NEEDLE SET | FIE | TERUMO MEDICAL, CORP. EAST | NA | UE2451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |