MAUDE Adverse Event Report: MCKESSON SURGICAL LUBRICANT; LUBRICANT, PATIENT

Model Number 16-8946

Device Problems Clumping in Device or Device Ingredient (1095); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Event Description

I have previously ordered and used a surgical lubricant mckesson mr #119-8946 - this is a 5 gram packet.It is a good product and it is made in the usa.My supplier substituted mckesson mfr #16-8946 which is made in (b)(4) and it is of very poor quality.Note that the last four digits of these two products are the same.It is the first 2-3 digits that are different.Three of the ingredients in the good product are not in the bad product.There is a phenomena called wetability that can be measured to determine how well something spreads.I am guessing that one of the ingredients in the good product enhances the wetability.It spreads very smoothly whereas the (b)(4) product beads up into little clumps.The (b)(4) product is unsuitable as a surgical lubricant for use in intermittent catheterization.This is not the fault of my supplier because they let me know that the usa product is no longer available.Mckesson medical-surgical inc.

• Brand Name: MCKESSON SURGICAL LUBRICANT
• Type of Device: LUBRICANT, PATIENT
• MDR Report Key: 7665758
• MDR Text Key: 113512847
• Report Number: MW5078277
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/03/2018

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: 11/07/2020
• Device Model Number: 16-8946
• Device Lot Number: CHB11-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 82