MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-13 for MONOJET 8881225307 * manufactured by Covidien.
[4122659]
Staff rn was using a monojet blood collection set to draw a blood sample on a patient. The blood draw could not be completed due to blood leaking around the connection site between the needle and the tubing. It was noted to be cracked. This required the patient to be restuck for blood draw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3537310 |
| MDR Report Key | 3537310 |
| Date Received | 2013-12-13 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-12-10 |
| Report Date | 2013-12-13 |
| Date Reported to FDA | 2013-12-13 |
| Date Reported to Mfgr | 2013-12-26 |
| Date Added to Maude | 2013-12-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOJET |
| Generic Name | TRAY, BLOOD, COLLECTION |
| Product Code | GJE |
| Date Received | 2013-12-13 |
| Model Number | 8881225307 |
| Catalog Number | * |
| Lot Number | 132350339X |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-13 |