MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for STANDARD AND SMALL RIGID TIP SUCTION WANDS SU-12202 manufactured by Sorin Group Usa, Inc..
[80565683]
The involved device is not available for return to sorin group usa. However, inventory of this product was identified and is available for return. If any additional information relevant to the reported event is received, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[80565684]
Sorin group received a report that the suction nozzle of the rigid tip suction wand disconnected from the handle while suctioning the pleural fluid during a procedure and fell inside the patient's chest cavity. The tip was recovered quickly and removed from the patient with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718850-2017-00012 |
| MDR Report Key | 6726431 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-07-10 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2017-07-19 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAN CEASAR |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | SORIN GROUP 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 | 2017-07-19 |
| Catalog Number | SU-12202 |
| Lot Number | 1706500150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA, INC. |
| Manufacturer Address | 14401 W 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |