MAUDE Adverse Event Report: BECTON-DICKINSON CHLORAPREP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Catalog Number 260815

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

Chloraprep obtained from supply cabinet.While removing from package the end of prep stick came off.Glass ampule fell to floor and broke.Lot: 0328213, exp: 11/2023, 26 ml orange applicator.Applicator not saved.Lot# above is on the becton-dickinson voluntary recall list issued 4/20/2021.

• Brand Name: CHLORAPREP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): BECTON-DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11840935
• MDR Text Key: 251141348
• Report Number: 11840935
• 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: 04/28/2021,04/27/2021

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: Health Professional
• Device Catalogue Number: 260815
• Device Lot Number: 0328213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1