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 2019-10-02 for HUDSON ET TUBE HOLDER, SMALL,W/BITE BLOCK 81804 manufactured by Teleflex Medical.
[183720606]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183720607]
Customer reported the "zip tie adjustment lever breaks off". This is the piece that secures the et tube. No patient harm or injury reported. No medical intervention needed. At the time of this report, the patient had been extubated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2019-00295 |
| MDR Report Key | 9147200 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-11 |
| Date of Event | 2019-09-11 |
| Date Mfgr Received | 2019-09-11 |
| Date Added to Maude | 2019-10-02 |
| 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 | VICTORIA SANDLIN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| 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, SMALL,W/BITE BLOCK |
| Generic Name | TRACHEAL TUBE FIXATION DEVICE |
| Product Code | CBH |
| Date Received | 2019-10-02 |
| Returned To Mfg | 2019-09-20 |
| Catalog Number | 81804 |
| Lot Number | 34831 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-02 |