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 2016-08-29 for HUDSON ADULT ISO-GARD DRAIN 830 manufactured by Teleflex Medical.
[53385942]
(b)(4). The results of the investigation are incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[53385943]
The customer alleges that the valve of the device leaks which causes water to spit out and lose volume from the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[57632961]
(b)(4). A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. The sample was not returned for evaluation; therefore, ten pieces of the same catalog number were selected from current production at the manufacturing facility. A visual exam was performed and no defects were observed on the samples. In addition, all ten pieces passed a leak test. In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; thus, any defects would be detected prior to release. The complaint could not be confirmed as the actual sample was not returned for evaluation, and no visual or functional issues were found on the samples taken from production.
Patient Sequence No: 1, Text Type: N, H10
[57632962]
The customer alleges that the valve of the device leaks which causes water to spit out and lose volume from the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2016-00180 |
| MDR Report Key | 5910813 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2016-10-13 |
| Date Added to Maude | 2016-08-29 |
| 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 ADULT ISO-GARD DRAIN |
| Generic Name | DRAIN, TEE (WATER TRAP) |
| Product Code | BYH |
| Date Received | 2016-08-29 |
| Catalog Number | 830 |
| Lot Number | 201313 |
| 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 | 2016-08-29 |