MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for STANDARD AND SMALL RIGID TIP SUCTION WANDS SU-20602 manufactured by Livanova Usa, Inc..
[130632956]
There was no patient involvement. Additional device information: lot number: multiple issues and multiple lot numbers (1813400128 and 1813400138) were reported by the customer. It is unknown which lot number(s) were affected by the reported issue. Expiration date: may 31, 2021 for both reported lot numbers. Device manufacture date: 1813400128 - may 14, 2018; 1813400138 - may 14, 2018. During follow-up communication with the customer, livanova requested additional information regarding the identity of the foreign material. The customer did not provide additional information and stated that we would be able to inspect the cannula upon return to livanova. The device has been requested for return to livanova for further investigation. If any additional information relevant to the reported issue is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[130632957]
Livanova received a report that multiple rigid tip suction wands were identified to have foreign bodies. It is unclear from the photographs and information provided if the foreign bodies were ink markings or particles, and whether they were inside or outside of the cannula tubing. This issue was discovered during incoming inspection at the distributor. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718850-2018-00023 |
| MDR Report Key | 8166705 |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-14 |
| 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 | NJEMILE CRAWLEY |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287575 |
| Manufacturer G1 | LIVANOVA USA, INC. |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STANDARD AND SMALL RIGID TIP SUCTION WANDS |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2018-12-14 |
| Catalog Number | SU-20602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA USA, INC. |
| Manufacturer Address | 14401 W 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-14 |