MAUDE Adverse Event Report: HOLLISTER LIETUVA UAB VAPRO PLUS POCKET; NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T

Model Number	71102-2-30
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr review on the lot number provided was found to be complete and accurate.Sterilization records reviewed and found to be in compliance with the quality standards for maintaining the required steriliity assurance level.No samples available for review.No causation was able to be established between the vapro catheters and the reported urinary tract infection.
Event or Problem Description
It was reported that the end user using the vapro plus pocket catheter experienced urine leakage from the connection between the catheter and leg bag.In addition, it was reported that the urine was not draining into the bag, that it is retracting and going back into the bladder and that it was causing uti's.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T
• Manufacturer (Section D): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., ltu LT-54 462; LH LT-54462
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., ltu LT-54 462; LH LT-54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048 ; 8479321271
• MDR Report Key: 22201566
• Report Number: 3016675012-2025-00004
• Device Sequence Number: 19975323
• Product Code: GBM
• UDI-Device Identifier: 00610075094394
• UDI-Public: (01)00610075094394(17)270101(30)3C(10)5A089
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 71102-2-30
• Device Catalogue Number: 71102-2-30
• Device Lot Number: 5A089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown