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 2018-09-19 for HUDSON HUMID-VENT 2 STRAIGHT FLEX 17732 manufactured by Teleflex Medical.
[120830977]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120830978]
Customer complaint alleges "approximately 30 minutes into uneventful nasal septoplasty case with the patient's head turned 180 degrees away, the ventilator sounded an apnea alarm. (cont. ) the culprit was found to be a clean "laceration" of the humid vent device at the junction of the hard plastic rim (connected to the endotracheal tube) and the first soft plastic ridge of the accordion tubing. Examination of the wrapper for this device showed no pre-existing cuts which might have compromised the device. The device worked fine for 30 minutes from its insertion. There was only an occasional surgeon's elbow near the humid-vent which was under sterile surgical drapes; no scalpel was near. This happened twice with two different patients. " first event captured in mfr. Rpt. 8040412-2018-00254.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00256 |
| MDR Report Key | 7890319 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-09-19 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-27 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-09-19 |
| 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 HUMID-VENT 2 STRAIGHT FLEX |
| Generic Name | CONDENSER, HEAT AND MOISTURE (ARTIFI |
| Product Code | BYD |
| Date Received | 2018-09-19 |
| Catalog Number | 17732 |
| 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 | 2018-09-19 |