MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-13 for MONOJECT * 8881225307 manufactured by Covidien.
[4074127]
While drawing blood, the blood leaked from the proximal end of the venipuncture tubing and leaked onto the patient's clothing. The tubing was defective and had a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3560680 |
| MDR Report Key | 3560680 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-11-13 |
| Date of Event | 2013-11-06 |
| Report Date | 2013-11-13 |
| Date Reported to FDA | 2013-11-13 |
| Date Reported to Mfgr | 2013-11-19 |
| Date Added to Maude | 2014-01-08 |
| 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 | MONOJECT |
| Generic Name | SET, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2013-11-13 |
| Model Number | * |
| Catalog Number | 8881225307 |
| Lot Number | 131150160X |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| 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 | 2013-11-13 |