MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS SU-29602 N/A manufactured by Sorin Group Usa.
[38542116]
Patient information not provided. Sorin group received a report that the tip of the rigid tip suction wand cannula was detached and left behind in the left atrium during the procedure. The tip was removed from the patient as soon as it was discovered that the tip was detached. There was no report of patient injury. The device has been requested for return to sorin group usa for further investigation. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[38542117]
Sorin group received a report that the tip of the rigid tip suction wand cannula was detached and left behind in the left atrium during the procedure. The tip was removed from the patient as soon as it was discovered that the tip was detached. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[54905686]
Sorin group received a report that the tip of the rigid tip suction wand cannula was detached and left behind in the left atrium during the procedure. The tip was removed from the patient as soon as it was discovered that the tip was detached. There was no report of patient injury. Two suction sump cannula and one suction sump tip were returned for investigation. Visual inspection of the two cannula confirmed that the tip was missing from both units. There was strong evidence of adhesive present on both returned units. Visual inspection of the returned tip found that it appeared to have been torn off of the rest of the tubing. Thirty rigid tip suction wand cannulae were pulled from three different lots from inventory for pull testing. All units sustained pull forces higher than the specifications for the product (10lbf) prior to failure of the device. The device history record for the reported lot number documented a pull force of 21. 41lbf during in-process testing. The device was determined to meet all applicable specifications and a root cause for the issue could not be determined. Although no defects were identified, several updates were made to the documentation (final assembly instructions and shop order detail) for this product to ensure adequate and consistent adhesion application.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2016-00028 |
| MDR Report Key | 5429420 |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-18 |
| Date of Event | 2016-01-18 |
| Date Mfgr Received | 2016-07-20 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2016-02-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CARRIE WOOD |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP USA |
| 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 | 3 |
| Brand Name | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2016-02-10 |
| Model Number | SU-29602 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA |
| Manufacturer Address | 14401 W. 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-10 |