MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2009-11-13 for HUDSON ONE WAY VALVE 1665 manufactured by Teleflex Medical.
[15538272]
The event is reported as: customer received package that was labeled catalog #1665, but the box contained catalog# 1664. Defect discovered upon receipt of product. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
[15887171]
Product sample has been requested but not received yet. Capa (b) (4) has been opened to address this issue by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2009-00067 |
| MDR Report Key | 1547540 |
| Report Source | 01,07,08 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-10-26 |
| Date Mfgr Received | 2009-10-26 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MANAGER |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ONE WAY VALVE |
| Generic Name | ONE WAY VALVE |
| Product Code | CBP |
| Date Received | 2009-11-13 |
| Model Number | NA |
| Catalog Number | 1665 |
| Lot Number | 02J0901967 |
| ID Number | NA |
| 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, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-13 |