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.
[153238201]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[153238202]
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 | 1417411-2019-00035 |
MDR Report Key | 8856970 |
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 |