MAUDE Adverse Event Report: TIDI PRODUCTS LLC 25217; URO-DRAIN COLLECTION BAG

Model Number	25217
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is submitted as a result of efforts associated with (b)(4) following the complaint handling process during the divesture of the tidi fenton, michigan facility.This capa was created to remediate and transfer complaint information previously handled by the tidi fenton facility.This is the 1st of two similar complaints reported for this product during 2017, neither of these events resulted in a patient, or caregiver injury.During 2017 products associated with this malfunction were returned for evaluation, an inventory inspection and complaint recreation were performed.This product contains two adaptor sizes; a 6.5 mm which is already inserted inside the hose and an additional 8 mm adaptor provided with the product.This complaint event is associated with the 8 mm adaptor.The product malfunction in this event was unable to be recreated at the fenton facility.Although the complaint was unable to be recreated, a process evaluation was performed and critical to quality component areas were identified, and adjusted to improve process consistency.Since these two events in 2017, there have been no similar product malfunctions reported to date for this product number.The original complaint number associated with this event was (b)(4) , the remediated complaint number is (b)(4).
Event or Problem Description
The customer's end user notified them that the drain bags are leaking.The leakage was noted after the adapter was inserted into the hose.The leakage appears to have occurred between the adapter and hose.

• Brand Name: 25217
• Common Device Name: URO-DRAIN COLLECTION BAG
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 9305811
• Report Number: 2182318-2019-00008
• Device Sequence Number: 2003258
• Product Code: MMZ
• UDI-Device Identifier: 00618125155682
• UDI-Public: 00618125155682
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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 Model Number: 25217
• Device Lot Number: 1153530816, 015371
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2019
• Patient Sequence Number: 1