MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative,oth report with the FDA on 2015-05-05 for PERFEKTUM TUBERCULIN GLASS SYRINGE 5205 manufactured by Cadence Inc..
[19504188]
On (b)(6) 2013 the customer reported syringe numeration is not centered over the graduation mark. There was no patient exposure (involvement) and no injury to the user.
Patient Sequence No: 1, Text Type: D, B5
[19627141]
Cadence acknowledges this report does not meet the thirty day reporting requirement. This was unintentional. This report is being filed after it was identified as non-complaint during an internal review of our complaint files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1213649-2015-00001 |
| MDR Report Key | 4756338 |
| Report Source | 07,COMPANY REPRESENTATIVE,OTH |
| Date Received | 2015-05-05 |
| Date of Report | 2013-08-07 |
| Date of Event | 2013-08-07 |
| Date Mfgr Received | 2013-08-07 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2015-06-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT TRAHAN |
| Manufacturer Street | 2080 PLAINFIELD PIKE |
| Manufacturer City | CRASTON RI |
| Manufacturer Country | US |
| Manufacturer Phone | 4019421031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1213649-7/9/15-01-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFEKTUM TUBERCULIN GLASS SYRINGE |
| Generic Name | SYRINGE |
| Product Code | DWO |
| Date Received | 2015-05-05 |
| Returned To Mfg | 2013-08-22 |
| Model Number | 5205 |
| Catalog Number | 5205 |
| Lot Number | 79748-05 |
| ID Number | NA |
| 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 | 2015-05-05 |