FDA Adverse Event
Malfunction
Summary report: N
PORTEX ANESTHESIA BREATHING CIRCUIT
MDR report key: 4232356
·
Received October 23, 2014
Report
- Report Number
- 2183502-2014-00793
- Event Type
- Malfunction
- Date Received
- October 23, 2014
- Date of Event
- September 5, 2014
- Report Date
- October 23, 2014
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- CAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: ONE USED ANESTHESIA BREATHING BAG WAS RETURNED WITHOUT THE BREATHING CIRCUIT TUBING. VISUAL INSPECTION OF THE BAG CONFIRMED THE PRESENCE OF A SMALL TEAR NEAR THE CONNECTOR. LEAKAGE TESTING OF THE BAG REVEALED THAT THE BAG DID NOT PASS STANDARD LEAKAGE TESTING. FURTHER INSPECTION OF THE LEAK POINT COULD NOT DETERMINE A ROOT CAUSE OF THE TEAR; HOWEVER, THE PHYSICAL CHARACTERISTICS COULD NOT BE ATTRIBUTED TO A MANUFACTURING ISSUE. THERE WAS NO EVIDENCE FOUND TO SUGGEST ANY INTRINSIC FAULT IN THE PRODUCT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE WAS IN USE WITH PATIENT WHEN A TEAR WAS FOUND ON THE ANESTHESIA BREATHING BAG. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674421 | PORTEX ANESTHESIA BREATHING CIRCUIT | CAI - CIRCUIT, BREATHING (W/ CONNECTOR, ADAPTOR, Y PIECE) | CAI | SMITHS MEDICAL INTERNATIONAL LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |