MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-02 for HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT 400340 manufactured by Teleflex Medical.
[153238469]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[153238470]
Customer complaint states: "presence of a bubble in the plastic part that connects the plug in of the oxygen to the aquapack bottle. So it occludes the flow of oxygen. " the condition of the patient is reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417411-2019-00034 |
| MDR Report Key | 8856838 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-02 |
| Date of Report | 2019-07-08 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2017-05-05 |
| Date Added to Maude | 2019-08-02 |
| 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,INT |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2019-08-02 |
| Returned To Mfg | 2019-07-08 |
| Catalog Number | 400340 |
| Lot Number | 220177 |
| 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 | 2019-08-02 |