MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-10-29 for HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR 003-40 manufactured by Teleflex Medical.
[165315788]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. In-process qa inspections shows one noncomformance; nonconfirming material was sorted for defect, re-inspected, and found to be acceptable. 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. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[165315789]
Customer reported air leaked from the adaptor when connected to the flow meter. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417411-2019-00058 |
| MDR Report Key | 9249590 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-11-20 |
| Device Manufacturer Date | 2018-06-13 |
| Date Added to Maude | 2019-10-29 |
| 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 | 900 WEST UNIVERSITY DR. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2019-10-29 |
| Returned To Mfg | 2019-10-31 |
| Catalog Number | 003-40 |
| Lot Number | 18B241 |
| 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 | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-29 |