MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-06-25 for MICRO-MATE TURBERCULIN GLASS SYRINGE 5208 manufactured by Cadence Inc..
[3556705]
On (b)(6) 2013, it was reported 2 glass syringes part number 5208 were received with no visible damage to the carton and found syringes broken when taken out of the box and prior to first use. There was no patient exposure and no injury to the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213649-2013-00023 |
| MDR Report Key | 3193259 |
| Report Source | 00 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-05-22 |
| Date Mfgr Received | 2013-05-22 |
| Device Manufacturer Date | 2012-02-12 |
| Date Added to Maude | 2013-09-18 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-MATE TURBERCULIN GLASS SYRINGE |
| Generic Name | SYRINGE |
| Product Code | DWO |
| Date Received | 2013-06-25 |
| Returned To Mfg | 2013-05-24 |
| Model Number | 5208 |
| Catalog Number | 5208 |
| Lot Number | 82350/1 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2013-06-25 |