MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; CATHETER,FOLEY,100% SILICONE,8FR,3ML,LF

Model Number	DYND11553
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an end user with advanced kidney disease with hydronephrosis who requires overnight catheterization to rest the bladder was experiencing more pressure than usual and not draining.Initially the reporter states, they removed the catheter and would re-insert another (same brand) catheter and end up with the same result.End user reports, "he couldn't exercise, eat comfortable and felt ongoing pressure backing-up into his bladder." the reporter states, the catheters were noted to have "lots of bubbles in it and did not seem to be draining much overnight.Reporter states, "we have used this same product for the past 3 months without issue, and then all of a sudden had multiple issues as though a slight change in manufacturing." reporter states, we had to change catheters to a different brand and eventually the end user felt better after five days.No additional details are available.There are no samples available for return and evaluation.There was no report of serious injury, medical intervention, or follow-up.However, due to the reported incident and in 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
It was reported the foley catheters were causing the end user "more pressure than usual and not draining.".

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100% SILICONE,8FR,3ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10395831
• Report Number: 1417592-2020-00077
• Device Sequence Number: 16884338
• Product Code: EZL
• UDI-Device Identifier: 10080196848836
• UDI-Public: 10080196848836
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DYND11553
• Device Catalogue Number: DYND11553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/12/2020
• 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
• Patient Age: 14 YR
• Patient Weight: 54