MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-11-19 for CATHETER AND CANNULA CV-4300 manufactured by Terumo Cardiovascular Systems Corp..
[5011190]
Upon receipt (inspection) of the device, the vendor reported that a stain was found on the stainless steel on the portion of the intracardiac sucker that goes to the machine side. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2014-00974 |
| MDR Report Key | 4279243 |
| Report Source | 01,07 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-10-28 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-10-28 |
| Date Added to Maude | 2014-12-01 |
| 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 | JAN WINDER |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER AND CANNULA |
| Generic Name | RIGID ADULT INTRACARDIAC SUCKER |
| Product Code | DTS |
| Date Received | 2014-11-19 |
| Model Number | CV-4300 |
| Catalog Number | CV-4300 |
| Lot Number | 0727723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |