FDA Adverse Event
Malfunction
Summary report: N
AIRLIFE VALVED TEE ADAPTER
MDR report key: 967122
·
Received May 9, 2007
Report
- Report Number
- 2026894-2007-00001
- Event Type
- Malfunction
- Date Received
- May 9, 2007
- Date of Event
- March 21, 2007
- Report Date
- March 21, 2007
- Manufacturer
- THAYER MEDICAL CORP.
- Product Code
- BZA
- PMA / PMN Number
- K882341
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DISTRIBUTOR STATED THAT THE DEVICE INVOLVED WAS DISCARDED. THE USER FACILITY REPORTED HAVING THREE LOTS OF 002061 ADAPTERS. DEVICES FROM THE SAME LOT AS THOSE PULLED FROM THE USER FACILITY MEET ALL PRODUCT SPECIFICATIONS. PRODUCT DESIGN MEETS ASTM DESIGNATION: "STANDARDS SPECIFICATION FOR CONICAL FITTINGS" "ANESTHETIC AND RESPIRATORY EQUIPMENT -- CONICAL CONNECTORS - PART 1: CONES AND SOCKETS." NO OTHER SIMILAR INCIDENTS HAVE OCCURRED.
Description of Event or Problem · 1
AN ADULT INTUBATED PT WAS RECEIVING AEROSOL THERAPY WITH THE AIRLIFE VALVED TEE ADAPTER 002061 ON A HUDSON VENTILATOR CIRCUIT. A RESPIRATORY THERAPIST INVOLVED STATED THE 002061 ADAPTER "SLIPPED OFF" THE CIRCUIT AND THE PT CODED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRLIFE VALVED TEE ADAPTER | VALVED TEE ADAPTER | BZA | THAYER MEDICAL CORP. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | HUDSON HEATED WIRE VENTILATOR CIRCUIT, |