MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 60/6

Lot Number	5198294
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in (b)(6).The patient reported cracked/broken tubing.The hose had gone off at the bracket as well.In the complaint investigation, it was found that the tubing was detached from the tubing connector due to missing glue.Furthermore, there was excess of glue present where the tubing was joined to the tubing connector.No further information available.

• Brand Name: CONTACT¿DETACH
• Common Device Name: CONTACT DETACH G29 60/6
• MDR Report Key: 8276824
• Report Number: 3003442380-2019-00259
• Device Sequence Number: 13834852
• Product Code: FPA
• UDI-Device Identifier: 05705244005716
• UDI-Public: 05705244005716
• Combination Product (Y/N): N
• PMA/510(K) Number: K041545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Expiration Date: 08/01/2020
• Device Lot Number: 5198294
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1