Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY CHLORAPREP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON AND COMPANY CHLORAPREP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE Back to Search Results
Model Number 930800
Device Problem Particulates (1451)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
At beginning of surgical site prep by registered nurse (rn) circulator, anesthesiologist noticed small glasslike shards on patient's left chest, informed this rn circulator of "glass like shard appearance." upon examination of patient's chest, health care provider was able to remove glass like shards without scratches or abrasions to patient's skin.Inspection of bd chloraprep¿ clear sponge revealed glass like shards coming from chloraprep sponge, also noted glass like shards remaining inside chloraprep packaging.A new bd chloraprep¿ clear applicator was obtained, broken per packaging instructions to activate solution into sponge, inspection of new sponge revealed no glass like shards.Patient's left chest was prepped for surgical procedure without further incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHLORAPREP
Type of Device
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key12719189
MDR Text Key279088891
Report Number12719189
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/21/2021
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 Model Number930800
Device Catalogue Number930800
Device Lot NumberNDC 54365-400-37
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2021
Event Location Hospital
Date Report to Manufacturer10/29/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23360 DA
-
-