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 2015-05-13 for HUDSON CIRCUIT ACCESSORY,HEATED WIRE, INSPIRAT 780-20 manufactured by Teleflex Medical.
[5776547]
The customer alleged that the circuit melted. The device was not in use on a pt at the time of the alleged issue. No report of a pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[13292222]
Qn#(b)(4). It is unk if the device sample is available for eval. 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. 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 eval. Customer complaint cannot be confirmed based only on the info 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 at the facility nor is 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
[23697972]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that several sections of the corrugated tubing were melted. No issues were found with the assembly of the heated wires. They were evenly distributed along the corrugated tubing and were assembled according to specification. The heated wires were disassembled in order to inspect the wires for exposed wire or knots, but no damages or knots were found. The total length of heater wire assembly was measured and it was found to be within specification. Functional testing was performed and no issues were detected. Based on the investigation performed, the reported complaint was confirmed. Although the complaint was confirmed, a root cause could not be determined. There were no issues found with the assembly of the heated wires, and they were evenly distributed along the corrugated tubing. The product ifu (instructions for use) states several warnings in order to avoid overheating the circuit.
Patient Sequence No: 1, Text Type: N, H10
[23697973]
The customer alleges that the circuit melted. The device was not in use on a patient at the time of the alleged issue. No report of a patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00142 |
| MDR Report Key | 4771451 |
| Report Source | 05,06,07 |
| Date Received | 2015-05-13 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-06-11 |
| Date Added to Maude | 2015-06-15 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| 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,HEATED WIRE, INSPIRAT |
| Generic Name | VENTILATOR CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-05-13 |
| Returned To Mfg | 2015-05-14 |
| Catalog Number | 780-20 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-05-13 |