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 2015-07-01 for HUDSON BREATHING CIRCUIT,HEATED WIRE NIV 780-98 manufactured by Teleflex Medical.
[6043775]
The customer alleges that there is a slight tear found in the circuit tubing. No patient injury or harm reported.
Patient Sequence No: 1, Text Type: D, B5
[13307391]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23703634]
(b)(4). The reported complaint that there was a slight tear found in the circuit tube during use was confirmed through visual inspection of the returned sample. The tear on the tube was identified and noted on the expiratory limb. A dhr review could not be conducted because the lot number was not provided. The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[23703635]
The customer alleges that there is a slight tear found in the circuit tubing. No patient injury or harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00185 |
| MDR Report Key | 4881972 |
| Report Source | 05,06,07 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-07-24 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 BREATHING CIRCUIT,HEATED WIRE NIV |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-07-06 |
| Catalog Number | 780-98 |
| 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 |