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

Catalog Number 260480 MX

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They report that when supplying the input it was found that the piece presents a foreign particle (apparently an insect) inside the primary packaging.

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo shows foreign matter inside the 1 ml pouch which verifies the reported issue.Without an actual sample, a definitive root cause could not be defined at this time.If a sample becomes available, bd will re-open and investigate accordingly.A production record review was completed for batch/lot 1184765 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.Records reviewed indicate that the lot passed all the in-process inspections.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

They report that when supplying the input it was found that the piece presents a foreign particle (apparently an insect) inside the primary packaging.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13192275
• MDR Text Key: 291868165
• Report Number: 3004932373-2021-00553
• Device Sequence Number: 1
• Product Code: KXF
• UDI-Device Identifier: 20885403428620
• UDI-Public: (01)20885403428620
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Number: 260480 MX
• Device Lot Number: 1184765
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other