MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 260299NSB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material no.: 260299nsb, batch no.: 0160547.It was reported shards of glass came out of the applicator and cut the patient.Our infusion team found shards of glass coming out of one of the applicators and cut a patient.I do not know the particular product#, as it was part of a kit, but below is a picture of it.This was a part of the trinity sterile iv start kit mfr cat# 50667.I will also be notifying trinity sterile about this.We were unable to get a product number of the tray, but here are the lot numbers in that par: lot#'s 600002, 600003, and 600004.

Manufacturer Narrative

Follow up emdr (b)(4).Bd was unable to perform a thorough investigation as no physical sample was provided provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Production batch history records for applicator material no.: 260299nsb batch no.: 0160547 was reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.

Event Description

Material no.: 260299nsb batch no.: 0160547.It was reported shards of glass came out of the applicator and cut the patient.Our infusion team found shards of glass coming out of one of the applicators and cut a patient.I do not know the particular product#, as it was part of a kit, but below is a picture of it.This was a part of the trinity sterile iv start kit mfr cat# 50667.I will also be notifying trinity sterile about this.We were unable to get a product number of the tray, but here are the lot numbers in that par: lot#'s 600002, 600003, and 600004.

• Brand Name: CHLORAPREP ONE STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11613685
• MDR Text Key: 255208588
• Report Number: 3004932373-2021-00169
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260299NSB
• Device Lot Number: 0160547
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other