MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-11 for HUDSON HUMID-FLO HME 19912 manufactured by Teleflex Medical.
[113752467]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113752468]
Customer complaint alleges the respiratory therapist states the device connection is loose and thus disconnects easily during patient use.
Patient Sequence No: 1, Text Type: D, B5
[117914747]
(b)(4). The actual sample was not returned; therefore ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect. All ten samples passed visual and leak testing. In addition, a plug test gauge and ring gauge test were conducted on the ten production samples to spot if the diameter of humid-flo connector which connects to the ventilator circuit or patient is out of specification. Both sides met the specification. A device history record review was performed and no relevant findings were identified. Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
Patient Sequence No: 1, Text Type: N, H10
[117914748]
Customer complaint alleges the respiratory therapist states the device connection is loose and thus disconnects easily during patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00179 |
| MDR Report Key | 7677466 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-11 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-24 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-07-11 |
| 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 | 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-FLO HME |
| Generic Name | CONDENSER, HEAT AND MOISTURE ( |
| Product Code | BYD |
| Date Received | 2018-07-11 |
| Catalog Number | 19912 |
| Lot Number | 201806 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-07-11 |