MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for ZOLL IVTM QUATTRO CATHETER IC-4593 8700-0783-01 manufactured by Zoll Circulation.
[184420482]
Zoll has not received the product for investigation. A follow-up report will be submitted when the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[184420483]
During ivtm therapy, 14 minutes after placement of the quattro catheter (lot # unknown), the user noticed blood in the start-up kit (suk) tubing due to suspecting catheter leak. The quattro catheter was removed and replaced. No further information was provided. No consequences or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00186 |
| MDR Report Key | 9765195 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-27 |
| 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 | MS. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL IVTM QUATTRO CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-02-27 |
| Model Number | IC-4593 |
| Catalog Number | 8700-0783-01 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |