MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS HYDROPHILIC IC 14FR 16IN; HYDROPHILIC INTERMITTENT URINARY CATHETER

Catalog Number 74144

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

The device history records were reviewed based upon the lot number provided and the records were found to be complete and accurate.The sterilization documentation for this lot was also reviewed and no out of specification results were found.The root cause of the reported urinary tract infection cannot be determined.Causation has not been established.

Event Description

It was reported that the hollister vapro plus hydrophilic intermittent catheter was not as moist as usual, was difficult to insert and difficult to remove from the urethra.It was reported that the end user used instillagel with the catheter and now has a uti and is on antibiotics.

Event Description

Follow up report.

Manufacturer Narrative

The unused samples from the same lot returned from the customer were tested.The catheters were not returned in their original box or original packing condition.The catheter in the pack passed all testing for coating lubricity, and the pack wasn't dry, in comparison to the issues noted by the complainant.Based on the manufacturing review and review of sterilization reports no links could be made to the reported defect.The root cause for the reported uti is unknown.

• Brand Name: VAPRO PLUS HYDROPHILIC IC 14FR 16IN
• Type of Device: HYDROPHILIC INTERMITTENT URINARY CATHETER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 18884597
• MDR Text Key: 337413665
• Report Number: 9616668-2024-00001
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: FDA PREMARKE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74144
• Device Lot Number: 3E233
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 114 KG