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 2019-08-20 for HUDSON 780-18 CIRCUIT W/ COLUMN 780-18KIT manufactured by Teleflex Medical.
[155059922]
(b)(4). The actual sample is not available for return; therefore, the customer provided a photo for evaluation. In the photo it can observed that the heater wire was detached from the connector. No other issues were observed. Without the 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
[155059923]
The complaint is reported as: the circuit wires came out of the yellow expiratory clip. Patient was on bubble cpap. No patient injury or consequence reported. The condition of the patient is reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00216 |
| MDR Report Key | 8912339 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-08-20 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-08-02 |
| Date Added to Maude | 2019-08-20 |
| 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 | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON 780-18 CIRCUIT W/ COLUMN |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2019-08-20 |
| Catalog Number | 780-18KIT |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |