MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-28 for HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O 780-36 manufactured by Teleflex Medical.
[5706332]
The customer alleges that the circuit had nicks/holes that were found during pre-testing. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
[13254674]
(b)(4). It is unk if the device 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. Thas an add'l test, (b)(4) samples of current production p/n 780-36 (circuit, htd dual limb w/water traps w/o) were reviewed and inspected for holes and tested according to tp-0145, and no issues were found than can lead to the condition reported by the customer. A dhr review could not be conducted since the lot number was not provided. No corrective actions can be established at this moment since the device sample or picture 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. If device sample becomes available at a later date, this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00133 |
| MDR Report Key | 4736405 |
| Report Source | 06,07 |
| Date Received | 2015-04-28 |
| Date of Report | 2015-04-03 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-03 |
| Date Added to Maude | 2015-06-09 |
| 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 | 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 CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-04-28 |
| Catalog Number | 780-36 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RTP NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-28 |