FDA Adverse Event
Malfunction
Summary report: N
PORTEX 15MM REUSABLE SWIVEL CONNECTOR
MDR report key: 4230543
·
Received October 10, 2014
Report
- Report Number
- 2183502-2014-00755
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Report Date
- October 9, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- BZA
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE WAS IN USE WITH A PT FOR AN UNK AMOUNT OF TIME WHEN THE CONNECTOR WAS FOUND LEAKING. THE CLINICIAN INCREASED OXYGEN FLOW TO THE PT TO COMPENSATE FOR THE LEAKAGE. THERE WERE NO ADVERSE EFFECTS TO THE PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640763 | PORTEX 15MM REUSABLE SWIVEL CONNECTOR | BZA | SMITHS MEDICAL MD, INC. | NA | 2500402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |