MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-04 for PORTEX ANESTHESIA BREATHING CIRCUIT 386000-NL manufactured by Smiths Medical International Ltd.
[4611626]
A report was receiving stating that during use of the listed device on a pt, the device's corrugated tubing was discovered to be torn and leaking. The circuit was disconnected and replaced. No adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5
[12058190]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2014-00371 |
| MDR Report Key | 3965958 |
| Report Source | 06 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-06-03 |
| Date of Event | 2013-10-17 |
| Date Facility Aware | 2013-10-17 |
| Report Date | 2014-06-03 |
| Date Reported to FDA | 2014-06-03 |
| Date Mfgr Received | 2013-10-17 |
| Date Added to Maude | 2014-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX ANESTHESIA BREATHING CIRCUIT |
| Generic Name | ANESTHESIA BREATHING CIRCUIT, ADULT |
| Product Code | OFP |
| Date Received | 2014-06-04 |
| Model Number | NA |
| Catalog Number | 386000-NL |
| Lot Number | 13AB3689 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Address | HYTHE, KENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |