MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX

Catalog Number	DYNC1674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6), "the foley was replaced.Urinary drainage bags have not been draining properly causing bladder spasms and leaking from the sp site and from the penis itself.He has required frequent suprapubic catheter changes as the urine does not drain properly into the drainage bag.He frequently has bladder spasms and low back pain due to the catheter not draining into the bag.I have personally been monitoring the situation and have changed his catheters.He has required daily sterile water flushes as interventions to attempt to relief the symptoms however we have been monitoring the urine draining into the bag and i have had to "milk" the tubing/ pinch the tubing constantly burping the tube to cause the air and urine to move through the bag.It starts to flow maybe 20-30 mls and then it stops and then i have to start manipulating the tubing up/down back and forth, grab the plastic bag where it meets the spout in the top of the bag and pull it apart causing pressure to be released, allowing it to flow.It has taken me at least 20+ minutes to fully drain the catheter and drainage bag tubing each day that i, times several times in a shift.I have disconnected the foley from the drainage bag to drain just the foley and to hold up the drainage bag tubing to try to make it flow and it still runs slow.It still doesn't drain due to pressure, air locking.Something.The urine does not flow smoothly when connected either, and a full line of urine sits in the catheter and in the full line of tubing.When it doesn't drain there is already enough backed up in the bladder causing leaking and overflow from the penis.It causes additional skin breakdown for this patient.The patient has been using more pain medication because of all of this" a sample is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer on (b)(6), "the foley was replaced.Urinary drainage bags have not been draining properly causing bladder spasms and leaking from the sp site and from the penis itself.He has required frequent suprapubic catheter changes as the urine does not drain properly into the drainage bag.".

• Common Device Name: BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19360355
• Report Number: 1417592-2024-00612
• Device Sequence Number: 3770724
• Product Code: KNX
• UDI-Device Identifier: 40080196840923
• UDI-Public: 40080196840923
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNC1674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown