MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for HEART CATH CUSTOM KIT 800537 manufactured by Roi, Llc.
[28949148]
Physician noted fiberous matter in syringe of heparin and verapamil that he was about to inject into the radial artery. Medication was injected into syringe from another syringe that came from a sterile heart cath pack. Syringes from the cath pack was set aside and new syringes were utilized with the opening of every cath pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057275 |
| MDR Report Key | 5167749 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-08-12 |
| Date Added to Maude | 2015-10-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART CATH CUSTOM KIT |
| Generic Name | DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OES |
| Date Received | 2015-10-16 |
| Catalog Number | 800537 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROI, LLC |
| Manufacturer Address | ST. LOUIS MO 63141 US 63141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-16 |