MAUDE Adverse Event Report: CURE MEDICAL LLC CURE MEDICAL CATHETER INSERTION KIT; CATHETER CARE TRAY

Model Number	K1
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user's technique was reviewed and it was found that he was handling an alcohol prep pad (manufactured by (b)(6)) that is not part of the sterile insertion kit.The user was using the bzk swab supplied with the kit and the alcohol prep pad to wipe down the gloves.The recommended technique does not call for using a separate alcohol prep pad.The bzk swab supplied in the sterile insertion kit is meant to be used to clean the urethral opening and not the gloves.It is unclear why the user was using the alternate technique and he was advised to discuss his catheterization technique with his doctor as it appears to deviate from accepted clinical practice.Handling of the alcohol prep pad (packaging is not sterile) during the insertion process may lead to contamination of the gloves which are later used to insert the catheter.This report is made for the insertion kit and a separate report is made for the catheter since it cannot be determined the extent to which either device may have caused or contributed to the adverse event.
Event or Problem Description
Routine intermittent catheter patient (user) acquired a uti while concurrently using both a cure medical brand intermittent catheter and catheter insertion kit (gloves, bzk wipe, collection bag, underpad, lubricating jelly).No specific problems were reported with the catheter or insertion kit but the user stated he had difficulty inserting the catheter.The user also reported he was not following the recommended technique which may introduce contamination that could cause or contribute to an infection.

• Brand Name: CURE MEDICAL CATHETER INSERTION KIT
• Common Device Name: CATHETER CARE TRAY
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 8384470
• Report Number: 3005471919-2019-00014
• Device Sequence Number: 11319627
• Product Code: OHR
• UDI-Device Identifier: 00815947020468
• UDI-Public: (01)00815947020468(17)200328(10)17B15702(241)K1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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 Expiration Date: 03/28/2020
• Device Model Number: K1
• Device Catalogue Number: K1
• Device Lot Number: 17B15702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 86