MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BAG,DRAINAGE,4L,A/R TOWER,LL,SLIDE TAP

Catalog Number	DYND25405S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a leak in the drainage bag was identified and the urinary catheter was removed and replaced.After multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient or product information to the manufacturer.No impact or adverse effect to a patient or a patient's stability was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention to removed and replace the urinary catheter, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a leak in the drainage bag was identified.The urinary catheter was removed and replaced.
Additional Manufacturer Narrative
Communication was received from the reporting facility on 03-may-2019.According to the reporting facility, after identifying the drainage bag leakage, only the drainage bag was replaced.The patient's urinary catheter was not removed and replaced as was reported in the previous medwatch.There was no impact or adverse effect to the patient or the patient's stability.The sample was reportedly discarded and unavailable to be returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: BAG,DRAINAGE,4L,A/R TOWER,LL,SLIDE TAP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8572984
• Report Number: 1417592-2019-00047
• Device Sequence Number: 13525936
• Product Code: KNX
• UDI-Device Identifier: 10080196004355
• UDI-Public: 10080196004355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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 Catalogue Number: DYND25405S
• Device Lot Number: 069 1807H011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention