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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON-DICKINSON CHLORAPREP SKIN PREP STICK; APPLICATOR, ABSORBENT TIPPED, NON-STERILE
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BECTON-DICKINSON CHLORAPREP SKIN PREP STICK; APPLICATOR, ABSORBENT TIPPED, NON-STERILE Back to Search Results
Catalog Number 930815
Device Problem Burst Container or Vessel (1074)
Patient Problem Laceration(s) (1946)
Event Date 07/13/2021
Event Type  malfunction  
Event Description
Nurse prepping patient's right arm for av fistula.Sterile scrub prep completed.Nurse squeezed then shook chloraprep stick.The end on the prep stick flew off and the glass cylinder flew out of the end of the handle towards the nurse's right shoulder and cheek.The glass shattered on the nurse and shards of glass fell on the sterile surgical field and on the patient.The sheet under the patient's arm was removed which contained glass shards.The patient's arm was inspected thoroughly by both rns in or.Several small shards removed from patient's arm.No visible harm to patient.Rn had minor cuts to right middle finger.
 
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Brand Name
CHLORAPREP SKIN PREP STICK
Type of Device
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Manufacturer (Section D)
BECTON-DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12575851
MDR Text Key274724367
Report Number12575851
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 Biomedical Engineer
Type of Report Initial
Report Date 10/01/2021
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 Number930815
Device Lot Number0328213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2021
Event Location Hospital
Date Report to Manufacturer10/05/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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