MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for HUDSON IN-LINE NEB TEE WITH VALVEM 1743 manufactured by Teleflex Medical.
[72543227]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[72543228]
The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product. No report of an injury or impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[75530631]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. A dimensional exam was also performed and the sample was found to be within specification. The returned sample could fit firmly with a nebulizer used at the manufacturing facility. Based on the investigation performed, the reported complaint of "device disconnects from nebulizer" could not be confirmed. There were no issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[75530632]
The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product. No report of an injury or impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2017-00129 |
| MDR Report Key | 6476249 |
| Date Received | 2017-04-10 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-01-25 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-04-10 |
| 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 | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON IN-LINE NEB TEE WITH VALVEM |
| Generic Name | TUBING, PRESSURE & ACCFESSORIES |
| Product Code | BYX |
| Date Received | 2017-04-10 |
| Returned To Mfg | 2017-04-17 |
| Catalog Number | 1743 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-10 |