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 2015-03-20 for HUDSON CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY 780-19 manufactured by Teleflex Medical.
[5767098]
The customer alleges that the circuit melted while on a pt. No report of pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[13113990]
(b)(4). A visual, functional and dimensional inspection of the prod involved in the complaint could not be conducted since the prod was not rec'd at out facility. A device history record review could not be conducted since the lot number was not provided. No corrective action can be established at this time since the device sample or a picture of it is not available for evaluation. Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being mfg at the time. If the physical sample becomes available this complaint will be reopened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00104 |
| MDR Report Key | 4627791 |
| Report Source | 05,06,07 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-02-26 |
| Date of Event | 2015-02-26 |
| Date Mfgr Received | 2015-02-26 |
| Date Added to Maude | 2015-05-07 |
| 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 |
| 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 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 CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-03-20 |
| Catalog Number | 780-19 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |