MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-04-15 for HUDSON DUAL HEATED DUAL DRAIN 880-36KIT manufactured by Teleflex Medical.
[5648502]
The customer alleges that the circuit wire on version 1 of iso-gard circuit melted the circuit. There was a volume loss through the melt point which did have an effect on the pt's end tidal co2 reading. The issue was corrected when the circuit was changed. There are no reports of pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[13193119]
(b)(4). The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report. A dhr review could not be conducted since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00119 |
| MDR Report Key | 4697509 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-15 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-01 |
| Date Mfgr Received | 2015-03-23 |
| Date Added to Maude | 2015-05-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON DUAL HEATED DUAL DRAIN |
| Generic Name | ADULT BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-04-15 |
| Returned To Mfg | 2015-03-31 |
| Catalog Number | 880-36KIT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRINGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-15 |