MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Model Number	71124-2-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	01/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the dhr of finish goods, packing, push fitting, sleeving, and coating processes and no issues identified.Non-conformance material records (ncmr) review was performed and no issues were identified.At this time, the root cause cannot be determined because all the potential root causes were checked, and no deviations were observed.No corrective actions have been determined at this time.A photo evaluation and sample return from the same box is pending investigation.A follow-up will be submitted once investigations are completd.
Event or Problem Description
It was reported that a 34-year-old male end user had been using the hollister vapro plus pocket during self-catheterization and reported that a 7 to 10 cm piece of the catheter broke off and ended up in his bladder.It was reported that he then went to the emergency room and was reportedly scheduled for surgery the next day to remove the broken catheter piece.Additional information received reported that the catheter fragment had remained in his bladder from a saturday to monday, when it was surgically removed.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER LIETUVA, UAB; oro parko g. 2, sergei; karmlavos sen.; kaunas, 54462 ; LH 54462
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24148567
• Report Number: 3016675012-2026-00001
• Device Sequence Number: 8969811
• Product Code: GBM
• UDI-Device Identifier: 00610075094462
• UDI-Public: (01)00610075094462(17)270901(30)30(10)5I169
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 71124-2-30
• Device Catalogue Number: 71124-2-30
• Device Lot Number: 5I169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Male