FDA Adverse Event
Malfunction
Summary report: N
15.5F X 32CM TITAN HD CATH
MDR report key: 1231309
·
Received October 28, 2008
Report
- Report Number
- 2518902-2008-00037
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 27, 2008
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE SAMPLE IS BEING RETURNED FOR EVALUATION. WITHOUT THE LOT NUMBER WE ARE UNABLE TO REVIEW THE MANUFACTURING RECORDS. MANY VARIABLES CONTRIBUTE TO THE ENCAPSULATION OF A TEXTILE. THESE INCLUDE FACTORS RELATED TO SURGICAL TECHNIQUE, PATIENT HEMATOLOGY, AND CONCURRENT DRUG THERAPY. WE ARE UNABLE TO DETERMINED THE CAUSE OR FACTORS WHICH CONTRIBUTED TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE PATIENT WENT OUT TO THE TOILET AND SAID THE LINE CAME OUT OF HIS NECK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15.5F X 32CM TITAN HD CATH | HEMODIALYSIS CATHETER | MSD | MEDCOMP | THD155432SE. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |