MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-11 for HUDSON ONE WAY VALVE 1644 manufactured by Teleflex Medical.
[96956241]
(b)(4). The device involved in this complaint has not been received by the manufacturer at the time of this report. The investigation into this complaint is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[96956242]
Customer complaint alleges the device is breaking during use, after being put on the patient. There is no report of patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00024 |
| MDR Report Key | 7181931 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-11 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2017-07-04 |
| Date Added to Maude | 2018-01-11 |
| 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 ONE WAY VALVE |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2018-01-11 |
| Catalog Number | 1644 |
| Lot Number | 74G1700488 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-01-11 |