MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-08-24 for TDXFLX SYSTEM 9520-15 manufactured by Abbott Manufacturing, Inc..
[682409]
The customer received four tafx valve blocks, list number 09520-15, with imx multivalve block labels affixed. These valve blocks were received on 05/23/06 in tafx valve block packaging. The customer verified the products were tdx valve blocks (one port).
Patient Sequence No: 1, Text Type: D, B5
[7811668]
The four returned tdx/tdxflx tafx valve blocks were visually examined and were found to be tafx valve blocks in tafx valve block packaging, labeled with manufacturing code 39. 05, with imx multivalve block labels attached to the front of the valve blocks. The date code stamp of 39. 05 indicates a manufacturing date of the 39th week of 2005 (the week of september 26, 2005). Customer complaint review from january 1, 2004 to august 1, 2007 identified three add'l complaints for tafx valve blocks mislabeled with imx multivalve block labels and this issue was previously investigated. The tafx valve blocks were quarantined. The manufacturer, festo corporation, inspected the product in stock for this issue and no add'l instances of this issue were identified. The tafx valve block has been included on the inspection required list at the manufacturer. The part number will remain on the list until a minimum of three lots of material have been acceptably produced. In addition, if non-conforming material is identified with this issue, add'l action(s) will be considered. The mislabeled tafx valve block could be installed on an imx analyzer, but would not be able to perform primes or assay runs, since the tafx valve block does not have the port #2 needed for the imx. There was no new deficiency found during the trending review (june 2007) concerning the imx and tdxflx systems that would suggest that the use of this product would cause some type of adverse health consequence or that the product is performing contrary to intended use or label claims. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2007-00399 |
| MDR Report Key | 902062 |
| Report Source | 04 |
| Date Received | 2007-08-24 |
| Date of Report | 2007-07-27 |
| Date of Event | 2007-06-05 |
| Date Mfgr Received | 2007-07-27 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-10-04 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDXFLX SYSTEM |
| Generic Name | AUTOMATED FPIA ANALYZER |
| Product Code | LCQ |
| Date Received | 2007-08-24 |
| Returned To Mfg | 2007-06-13 |
| Model Number | NA |
| Catalog Number | 9520-15 |
| Lot Number | 39.05 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 881388 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-24 |