MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM; VAPRO PLUS POCKET

Catalog Number	71144
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the hollister vapro plus pocket hydrophilic intermittent catheter was inserted for about 3 minutes, the nurse tried to remove it and it was stuck.It was reported that the nurse had the charge nurse come to assist her and they had to pull very hard to remove it.It was further reported that about 24 hours later the end user developed a uti and had to be readmitted to the acute hospital for treatment.
Additional Manufacturer Narrative
Samples available for investigation but not yet received.Hollister verified that the lot was sterilized in accordance with the dmr.In addition, a review of the dhr found the records to be complete and accurate.The root cause of the reported event cannot be determined.
Additional Manufacturer Narrative
Unused samples from the same lot of production received from customer and evaluated in the manufacturing plant.The samples were reviewed and tested; and no issues were observed.The root cause of the reported issue could not be determined.Causation between the catheter use and the reported issue could not be confirmed.

• Brand Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM
• Common Device Name: VAPRO PLUS POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• 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. 60048-3781 ; 8479321271
• MDR Report Key: 17903812
• Report Number: 3016675012-2023-00003
• Device Sequence Number: 18198988
• Product Code: GBM
• UDI-Device Identifier: 00610075065332
• UDI-Public: 00610075065332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: Health Professional
• Device Expiration Date: 01/01/2025
• Device Catalogue Number: 71144
• Device Lot Number: 2L139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male