MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY CHLORAPREP ONE-STEP 1ML APPLICATOR; APPLICATOR, ABSORBENT TIPPED, STERILE

Catalog Number 260480

Device Problem Crack (1135)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 09/20/2019

Event Type  Injury  

Event Description

Chloraprep one-step 1ml device malfunctioned.The plastic body cracked during use and lacerated my finger with a piece of shattered glass.This caused a deep laceration of my right thumb and despite have the glass removed, the pain persists.Fda safety report id # (b)(4).

• Brand Name: CHLORAPREP ONE-STEP 1ML APPLICATOR
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 12099141
• MDR Text Key: 259618472
• Report Number: MW5102214
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 05436540006
• UDI-Public: 054365-400-06
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 40 YR
• Patient Weight: 86