MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2013-05-30 for BULKHEAD ADAPTER 6143 manufactured by Cadence Inc..
[3529404]
On (b)(6) 2013, it was reported the adapter did not have a through-hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213649-2013-00020 |
| MDR Report Key | 3145180 |
| Report Source | 07,08 |
| Date Received | 2013-05-30 |
| Date of Report | 2013-05-16 |
| Date of Event | 2013-04-16 |
| Date Mfgr Received | 2013-04-16 |
| Device Manufacturer Date | 2012-09-05 |
| Date Added to Maude | 2013-08-19 |
| 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 | ROBERT TRAHAN |
| Manufacturer Street | 2080 PLAINFIELD PIKE |
| Manufacturer City | CRANSTON RI 02921 |
| Manufacturer Country | US |
| Manufacturer Postal | 02921 |
| Manufacturer Phone | 4019421031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BULKHEAD ADAPTER |
| Generic Name | ADAPTER |
| Product Code | DWO |
| Date Received | 2013-05-30 |
| Returned To Mfg | 2013-04-29 |
| Model Number | 6143 |
| Catalog Number | 6143 |
| Lot Number | W002470/1 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CADENCE INC. |
| Manufacturer Address | 2080 PLAINFIELD PIKE CRANSTON RI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-30 |