MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-19 for HUDSON CIRCUIT,HTD INSP LIMB W/O EXHALATION VL 780-31 manufactured by Teleflex Medical.
[23395944]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility. The device history record (dhr) of batch number 02g1100171 that belong to catalog number 780-31 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled & inspected according to our specifications. No corrective action can be established at this moment since the device sample or picture of it are available for evaluation. Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint. 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 manufactured at the time. If device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[23395945]
The customer alleges that the tube melted and the heating wire was exposed. A new kit was used without issue. No health damage to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00270 |
| MDR Report Key | 5013146 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-19 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-08-03 |
| Device Manufacturer Date | 2011-06-30 |
| Date Added to Maude | 2015-08-19 |
| 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 | 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,HTD INSP LIMB W/O EXHALATION VL |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-08-19 |
| Catalog Number | 780-31 |
| Lot Number | 02G1100171 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-19 |