MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number	5111-00200-060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the ring of 2.0mm coupler detached from the u-port.This was observed during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.The jaw assembly and two 2.0mm coupler rings were returned, free floating in the inner tray of the coupler packaging with the lid taped to the tray.The rings and the left and right jaws of the jaw assembly showed signs of use (manipulation marks, gouges) which is consistent with the complainant¿s statement that the alleged event occurred during patient use.The rings were returned in a dislodged state which leads to a confirmation of the reported event of ¿ring dislodgement¿.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER
• Common Device Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10066238
• Report Number: 1416980-2020-02763
• Device Sequence Number: 13647278
• Product Code: MVR
• UDI-Device Identifier: 10844735002642
• UDI-Public: 10844735002642
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5111-00200-060
• Device Lot Number: SP1PJ301405992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1