MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO; NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T

Model Number	72144
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review and sterilization documentation review were conducted based on the lot number provided and the records were found to be complete and accurate.Sample available but not yet tested.Complaint data review was conducted, and no adverse trends observed.It cannot be determined if the bend in the silicone petal on the introducer tip occurred before or during use.The root cause of the reported bleeding and uti cannot be determined.Causation between the catheter use and the reported bleeding and uti has not been established.Udi information provided but not gudid information since this product is not sold in the us.A similar product, sku 74144, is sold in the us.
Event or Problem Description
It was reported that an end user who had been using the vapro urethral urinary catheters for 20 years started noticing a small amount of blood when catheterizing.It was reported that after using the catheter, the end user observed that one of the silicone petals on the catheter's introducer tip was bent outward.It was further reported that days later he began to feel unwell, had a urinalysis conducted, and was informed by his gp that he had a uti and needed to take a 7-day course of antibiotics.
Additional Manufacturer Narrative
An examination of the actual complaint sample was carried out.Although the reported bent introducer tip petal was confirmed with the sample return, based on the assessment of the bent petal, and the details provided by the end user/patient, it is highly unlikely that use of one product with a bent petal would cause urethral trauma, but cause more urethral discomfort if the end user / patient had sensation.Based on review of this product per the end user / patient feedback, it is uncertain where the blood and droplets of blood was observed, apart from the blood called out in the urine specifically, which wouldn't be related to the protective tip.The causation between the bent petal and the uti and bleeding could not be clearly established.

• Brand Name: VAPRO
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 20438359
• Report Number: 9616668-2024-00006
• Device Sequence Number: 8406058
• Product Code: GBM
• UDI-Device Identifier: 00610075081257
• UDI-Public: (01)00610075081257(17)251201(30)30(10)3K053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2025
• Device Model Number: 72144
• Device Catalogue Number: 72144
• Device Lot Number: 3K053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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: 74 YR
• Patient Sex: Male