MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-05-07 for HUDSON TRACH-VENT+CLEAN 41312U manufactured by Teleflex Medical.
[107466196]
(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
[107466197]
Customer complaint alleges the suction port of the trach-vent was blocked. Alleged issue reported as detected during use. It was reported there were no consequences for the patient. The device was changed with another. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00116 |
| MDR Report Key | 7490382 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2017-10-01 |
| Date Added to Maude | 2018-05-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON TRACH-VENT+CLEAN |
| Generic Name | CONDENSER, HEAT AND MOISTURE |
| Product Code | BYD |
| Date Received | 2018-05-07 |
| Returned To Mfg | 2018-06-04 |
| Catalog Number | 41312U |
| Lot Number | 201741 |
| 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 | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |