MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2009-01-22 for ONE WAY VALVE, FEMALE TO MALE 1665 manufactured by Teleflex Medical.
[1202671]
The description of complaint was reported as: product provided was in a incorrectly labeled package. The product was being used by and end user. It was quickly identified as being wrong product when patient communicated that she was not getting oxygen and product was switched out. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8462245]
Sample requested, but not received at the time of this report. The results of the investigation are not available at the time of this report. A follow up investigation report will be sent when available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2009-00005 |
| MDR Report Key | 1365955 |
| Report Source | 01,04 |
| Date Received | 2009-01-22 |
| Date of Report | 2009-01-08 |
| Date of Event | 2008-12-08 |
| Date Mfgr Received | 2009-01-08 |
| Date Added to Maude | 2010-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR. |
| Manufacturer Street | 4024 STIRRUP CREEK DRI. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE WAY VALVE, FEMALE TO MALE |
| Generic Name | ONE WAY VALVE |
| Product Code | BYW |
| Date Received | 2009-01-22 |
| Model Number | NA |
| Catalog Number | 1665 |
| Lot Number | 1506909306 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-22 |