MAUDE Adverse Event Report: READYCARE CINCINATTI E-Z LUBE JELLY; LUBRICATING JELLY

Catalog Number 000303

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported that patient experienced 3 uti's in a 2 month period.

Manufacturer Narrative

Lube jelly is used 3 times daily during catheterization procedures.Individual packets of lube jelly are used for each catheterization.A 12 french coude tip sterile catheter is used.There is no indwelling catheter.This patient has required this procedure since he was 1 years old.He is a quadraplegic due to transverse myelitis.He has a spastic bladder and is treated with ditropan.He was diagnosed with 3 uti's in less that 2 months and was treated with antibiotics.Th root cause of the uti's was not determined.Unused samples from the same lot were returned for evaluation.Microbial testing was performed on those, as well as on retained unsterile samples from the same production lot.Al samples met specifications with no growth recovered.We have no information to suggest the lubricating jelly was a cause or contributing factor to the reported incident.The mother of the patient is looking at other products they use that could be possible contributing factors to the infections, including but not limited to, the catheter and gloves.

• Brand Name: E-Z LUBE JELLY
• Type of Device: LUBRICATING JELLY
• Manufacturer (Section D): READYCARE CINCINATTI; cincinnati OH
• Manufacturer Contact: sherri weems-christie ; 1900 section rd; cincinnati, OH 45237 ; 5134583840
• MDR Report Key: 4730738
• MDR Text Key: 5585579
• Report Number: 1022110-2015-00002
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 000303
• Device Lot Number: 972129
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR