MAUDE Adverse Event Report: BECTON DICKINSON CHLORAPREP; APPLICATOR, ABSORBENT

Device Problem Packaging Problem (3007)

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

Event Date 09/26/2019

Event Type  malfunction  

Event Description

Chloraprep sticks looking like they are activated when we get them in the hand pack.They still activate when popped and have a full liquid sponge, but there is concern that because the dye is showing we could be losing alcohol via evaporation and not have the right amount to prep.These have all been pulled from stock.Company has responded to two formal complaints indicating they do not believe this to be a big problem.They indicated they will continue to track and trend this defect.We do not believe this to be an appropriate response to this issue and we continue to have concerns regarding sterility and volume of the product for use.

• Brand Name: CHLORAPREP
• Type of Device: APPLICATOR, ABSORBENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr; franklin lakes , NJ 07417
• MDR Report Key: 9368642
• MDR Text Key: 167829886
• Report Number: 9368642
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1