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

Device Problems Break (1069); Defective Device (2588)

Patient Problem Abrasion (1689)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

While starting iv access the patient was scratched by a small piece of glass/plastic from within the chlorahexidine scrub.The rn had noticed scratch marks in the area cleaned and asked the patient about them patient verbalized that they did not have those prior.The staff rn's investigated and found a small shard of glass/plastic had worked its way out of the plastic and into the foam covering that cleanses the patient's skin.

• Brand Name: CHLORAPREP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON- STERILE
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 16929807
• MDR Text Key: 315191498
• Report Number: 16929807
• 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: 04/04/2023

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
• 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: 04/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other