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

Lot Number	5167080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 the united states.It was reported that the quick release portion of the contact detach fell off prior to use.Patient's mother stated that it looked like there was no glue holding the quick release to the tubing.Upon investigation, it was found that the tubing was detached from the tubing connector due to missing glue.Furthermore, a drop of glue on tubing connector was found.No further information available.

• Brand Name: CONTACT¿DETACH
• Common Device Name: CONTACT DETACH G29 60/6
• MDR Report Key: 8463103
• Report Number: 3003442380-2019-00730
• Device Sequence Number: 16551295
• 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: 10/01/2021
• Device Lot Number: 5167080
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1