MAUDE Adverse Event Report: CHESTER PACKAGING LLC LUBRICANT JELLY PACKETS EZ

Catalog Number 00303

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

Patient Problem Urinary Tract Infection (2120)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

Mom called in to find out if there have been any recalls on the lubricant jelly packets (there was one in 2011).I informed her that there currently is not a recall, and she informed me that since the beginning of (b)(6) 2015, patient has had 2 confirmed uti's and she is thinking he is getting another one currently.We decided that she should stop using the current packets and we sent out another box with a different lot number.Mom will contact me if patient has any further uti's.We are unsure if it is the lubricant jelly packets that are causing him to have uti's, but due to the recall in 2011, we decided to change to a different lot number of the same product to see if this helps.Mom uses sterile gloves and catheters.

• Brand Name: LUBRICANT JELLY PACKETS EZ
• Type of Device: LUBRICANT JELLY PACKETS EZ
• Manufacturer (Section D): CHESTER PACKAGING LLC; cincinnati OH 45237
• MDR Report Key: 4643392
• MDR Text Key: 5753864
• Report Number: MW5041685
• Device Sequence Number: 1
• Product Code: KMJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 00303
• Device Lot Number: 972129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2015
• Patient Sequence Number: 1
• Patient Age: 15 YR