MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-07-01 for HUDSON CIRCUIT ACCESSORY,HTD WIRE, INSPIRATORY 780-19 manufactured by Teleflex Medical.
[6059821]
The customer alleges that that breathing circuit melted while in use. The customer alleges that the wires were bunched up (within the circuit) which could have caused a hot spot. No patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[13308850]
(b)(4). Evaluation codes: conclusion(s) - a conclusion code could not be chosen. The complaint was confirmed, but the root cause is unknown. Two pictures of the unit of catalog 780-19 (circuit accessory (htd wire, inspiratory), were received for analysis. They were visually inspected founding a bunch of wires that may have caused the melt of the corrugated tube. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record of batch number's (b)(4), (b)(4), (b)(4) and (b)(4) that belong to catalog number 780-19 have been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. No non conformance reports were originated for the lot numbers in question that can be associated to the complaint reported. The device history records shows that the products were assembled & inspected according to our specifications. Other remarks: the customer complaint was confirmed based on the visual inspection of the received pictures, because a melted section on the corrugated tubing was observed. However, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint. If device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[23703487]
(b)(4). The sample was received for evaluation. A visual exam was performed and it was observed that the circuit was burned/melted at the patient end. It was also detected that there was "bunched" or "gathered" excessive wire at the patient end. Functional testing was performed. The volt/ohm resistance of the circuit was measured to ensure the correct wire was used in the manufacturing of the circuit. The resistance reads 13. 7 ohms which is well within the specified tolerance of 12. 8 - 14. 3 ohms. Based on the physical evidence of the incident, the complaint is confirmed; however, a root cause could not be established. It would be extremely unlikely that the "bunched" or "gathered" wires would have been caused by the manufacturing process. Due to the tightly gathered bunch of wires, it would also be highly unlikely that this condition could have been caused by normal handling/and or shipping. It is possible that there was an accidental separation of the connector at the patient end from the corrugated blue tubing. In a scenario such as that, an undetermined length of wire could be exposed which would have been dragging the return wire loop down the blue tubing toward the patient end. Other remarks: it would be virtually impossible for the exposed wire (loop) to be evenly re-routed in the corrugated blue tubing. An operator or clinician who was attempting to put the circuit into use could have "pushed" the exposed wire back into the end of the circuit which would have resulted in the "bunched" affect as seen in the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[23703568]
The customer alleges that breathing circuit melted while in use. The customer alleges that the wires were bunched up (within the circuit) which could have caused a hot spot. No patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00177 |
| MDR Report Key | 4882374 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-07-01 |
| 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 | 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,HTD WIRE, INSPIRATORY |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-07-08 |
| Catalog Number | 780-19 |
| Lot Number | 02J100454 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |