MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO POCKET

Model Number	70144-30
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was completed for the reported lot(s), and no manufacturing deviations or non-conformances were identified.A review of complaint data did not reveal any emerging trends or signals related to urinary tract infections associated with the reuse of this single-use device.The device is labeled for single-use only, and reuse may increase the risk of infection.No additional corrective or preventive actions are warranted at this time based on the available information.
Event or Problem Description
It was reported that certain vapro catheters exhibited kinking at the midsection, which impeded sufficient insertion into the urinary tract, thereby preventing urine from entering and draining through the catheter.It was further reported that when kinking occurred, the end user attempted to manually straighten the catheter, after which the lubrication appeared inadequate to support reinsertion.Additionally, it was reported that the end user reused catheters when supply was low and has subsequently experienced urinary tract infections.
Event or Problem Description
Five unused vapro samples were returned from the end user and sent to the manufacturing location.
Additional Manufacturer Narrative
The unused samples that were returned to the manufacturing facility underwent product testing.Kink testing was completed on the returned samples and kinking failures were not observed.The catheters are designed to be single use only.The root cause of the catheter kinking cannot be definitively determined but may be due to multiple insertion attempt with the same catheter by the end user.A root cause of the reported uti and causation could not be determined.

• Brand Name: VAPRO POCKET
• Common Device Name: VAPRO POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, county mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 23485075
• Report Number: 9616668-2025-00030
• Device Sequence Number: 10494064
• Product Code: GBM
• UDI-Device Identifier: 00610075093076
• UDI-Public: (01)00610075093076(17)270601(30)30(10)5F043(93)X3
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Model Number: 70144-30
• Device Catalogue Number: 70144-30
• Device Lot Number: 5F043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male