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 2015-07-27 for HUDSON CIRCUIT,HTD DUAL LIMB 780-35 manufactured by Teleflex Medical.
[6254707]
The customer alleges that when the dropline from the circuit touched the plastic; it almost melted. No patient injury reported. Per the end-user; they may have contributed to the alleged issue (low flow or no flow).
Patient Sequence No: 1, Text Type: D, B5
[14221127]
(b)(4). It is unknown if the device sample is available for evaluation. 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 moment since the device sample or picture of it are not 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 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
| Report Number | 3004365956-2015-00203 |
| MDR Report Key | 4942726 |
| Report Source | 05,06,07 |
| Date Received | 2015-07-27 |
| Date of Report | 2015-07-08 |
| Date of Event | 2014-06-14 |
| Date Mfgr Received | 2015-07-08 |
| Date Added to Maude | 2015-07-27 |
| 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 | RESPIRATORY THERAPIST |
| 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,HTD DUAL LIMB |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-07-27 |
| Catalog Number | 780-35 |
| Device Availability | N |
| 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 | 2015-07-27 |