MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-05 for HUDSON ONE WAY VALVE, FEMALE TO MALE 1665 manufactured by Teleflex Medical.
[4555036]
The complaint was reported as: the customer alleges that the resistance in the one way valve is too great. The reported issue detected during testing set-up.
Patient Sequence No: 1, Text Type: D, B5
[11838514]
A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. A record review of the device history record (dhr) showed that there were no issues related to this complaint neither on the product nor its components during the mfr of the material. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. If the defective sample becomes available, this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00054 |
| MDR Report Key | 3752979 |
| Report Source | 06 |
| Date Received | 2014-02-05 |
| Date of Report | 2014-01-14 |
| Date of Event | 2014-01-06 |
| Date Mfgr Received | 2014-01-14 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-05-12 |
| 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 | MARGIE BURTON, CLINICAL SPECIALI |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. INDUSTRIAS 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ONE WAY VALVE, FEMALE TO MALE |
| Generic Name | ONE-WAY VALVE |
| Product Code | CBP |
| Date Received | 2014-02-05 |
| Catalog Number | 1665 |
| Lot Number | 02F1300863 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-05 |