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

Catalog Number	71144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Actual product sample not saved.Photo of actual sample not available.Customer returned unused samples from same lot of production to hollister for testing.No defects found in returned samples and passed all testing.Dhr (device history records) review completed on lot number provided and was found to be complete and accurate.No adverse complaint trends for this type of complaint observed and this appears to be an isolated event.The root cause of the reported event cannot be determined.
Event or Problem Description
It was reported that a nurse who was catheterizing a male patient with a hollister vapro urinary catheter to collect urine for a urinalysis observed that part of the catheter appeared missing when withdrawn from the patient's urethra.It was reported that the nurse inserted the catheter without any difficulty and attempted to withdraw it approximately 5 minutes later when there was some resistance and she had to use a little force to remove it.It was reported that post-catheterization, the doctor ordered a ct scan and then performed a cystoscopy.It was reported that he removed a catheter fragment approximately 9 inches long from the patient's bladder.It was further reported that he ordered the use of a foley for 24 hours post procedure.It was reported that the doctor did not save or take a picture of the catheter fragment but reported that it looked like a clean break.

• Brand Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM
• Common Device Name: VAPRO PLUS POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• 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., IL 60046 ; 8479321271
• MDR Report Key: 19071839
• Report Number: 3016675012-2024-00002
• Device Sequence Number: 17307920
• Product Code: GBM
• UDI-Device Identifier: 00610075065332
• UDI-Public: 00610075065332
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71144
• Device Lot Number: 3B089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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 Sex: Male