MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI HYDROPHILIC IC CH14 40 CM

Catalog Number	82144-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user who uses intermittent catheters developed a uti while using the hollister onli intermittent urinary catheter.The end user reported that he has a spinal cord injury and has no sensation.He said he was experiencing difficulties inserting the catheters and felt resistance during insertion.He said he developed urinary leakage, which is his typical symptom of a uti.He said his doctor diagnosed him with a uti and said the catheterization process probably caused inflammation leading to the uti.He stated the doctor placed him on antibiotics and the end user is now feeling fine.The end user stated he normally experiences 3 utis a year.
Additional Manufacturer Narrative
A review of complaints for this product over the last 3 years and no adverse trends observed.Device history records (dhr) review completed and the records were found to be complete and accurate.The product ifu and risk assessment was reviewed for adequacy and no issues identified.Complaint sample requested but not yet received.A causal relationship between the use of the catheters and urinary tract infections could not be determined.
Additional Manufacturer Narrative
Twenty-six unused catheters from the customer were received and tested.The lubricity testing showed that all of the samples exhibited lubricity equal to or greater than the lubricity of gel-based catheters.Specifically, two samples were equal to gel-based catheter lubricity and the rest were equal to hydrophilic-based catheter lubricity.In order to achieve consistant catheter lubricity equal to hydrophilic-based catheters, a capa was initiated.

• Brand Name: ONLI HYDROPHILIC IC CH14 40 CM
• Common Device Name: ONLI HYDROPHILIC IC CH14 40 CM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 15536902
• Report Number: 9616668-2022-00005
• Device Sequence Number: 6073738
• Product Code: GBM
• UDI-Device Identifier: 00610075060665
• UDI-Public: 00610075060665
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 82144-30
• Device Lot Number: 2E053 & 2E283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 75 KG