MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-09 for HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK 81802 manufactured by Teleflex Medical.
[183699443]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183699444]
Customer reported "ett holder was placed for approx 10-12 hours. When a therapist came into the patient room to do an assessment when it was noticed that the ett clamp had loosen to the point the ett was not secure. ". The ett holder was replaced. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2019-00297 |
| MDR Report Key | 9173145 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-09 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-10-31 |
| Date Added to Maude | 2019-10-09 |
| 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 | 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 ET TUBE HOLDER, STANDARD, W/BITE BLOCK |
| Generic Name | TRACHEAL TUBE FIXATION DEVICE |
| Product Code | CBH |
| Date Received | 2019-10-09 |
| Catalog Number | 81802 |
| Lot Number | UNKNOWN |
| 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 | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-09 |