MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2013-10-17 for 3CC MONOJECT SYRINGES 300-01 manufactured by Perfusion Systems.
[19389863]
Product analysis: no product was returned for analysis. Conclusion: the device history record could not be reviewed as no lot number was provided. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19485756]
Medtronic received information that during use, the plunger on this hms plus syringe would not plunge and therefore would not dispense blood into the heparin assay cartridge. In attempting to transfer blood from one syringe to another syringe, the slip-tip disengaged, resulting in blood spraying onto the user's protective glasses and mask, and possible spray into the user's eye. The patient was (b)(6) positive, and the user went to the emergency room for blood testing. Blood test results are pending. User is taking preventative medication prescribed by the emergency room as a precautionary measure. Product will not be returned for analysis, as it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[101846402]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2013-00051 |
| MDR Report Key | 3416969 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-10-17 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-09-16 |
| Date Mfgr Received | 2013-09-25 |
| Date Added to Maude | 2013-10-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE GAFFNEY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635265629 |
| Manufacturer G1 | MEDTRONIC STRUCTURAL HEART |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3CC MONOJECT SYRINGES |
| Generic Name | SYRINGE, CARTRIDGE |
| Product Code | EJI |
| Date Received | 2013-10-17 |
| Model Number | 300-01 |
| Catalog Number | 300-01 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 80134 US 80134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-17 |