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

Catalog Number 270449

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

Patient Problem Abrasion (1689)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Annex e- e1701 abrasion.Annex f- f25 unanticipated adverse device effect.Annex a- a24- adverse event without identified device or problem.

Event Description

Material no.: 270449, batch no.: 8264564.It was reported that two members of the staff have had a sharps injury due to the glass breaking through the plastic.Per complaint form: i spoke to helen on the phone they are in radiology and used the chloraprep sepp that is part of the rocialle cannulation pack that is used in wales.They have used the product for a long time but two members of staff have had a sharps injury due to the glass breaking through the plastic.Also below please see the initial communication sent to me via the product manager.Contact info omitted.Business unit: infection prevention product line: chloraprep enquiry: a couple of my staff and cut their fingers recently using chloraprep sepp 0.67ml.This could be a batch issue? batch number 8264564.

Event Description

Material no.: 270449, batch no.: 8264564.It was reported that two members of the staff have had a sharps injury due to the glass breaking through the plastic.Per complaint form: i spoke to (b)(6) on the phone they are in radiology and used the chloraprep sepp that is part of the rocialle cannulation pack that is used in wales.They have used the product for a long time but two members of staff have had a sharps injury due to the glass breaking through the plastic.Also below please see the initial communication sent to me via the product manager.Contact info omitted.Business unit: infection prevention.Product line: chloraprep.Enquiry: a couple of my staff and cut their fingers recently using chloraprep sepp 0.67ml.This could be a batch issue? batch number 8264564.

Manufacturer Narrative

The batch record (270449 - 8264564) was reviewed, and no non-conformances were noted during the manufacturing of this lot.Current process failure mode and effects analysis refers incorrect placement of foam or incorrect gluing of foam as a possible process failure mode, but without a returned sample it is not possible to determine if this is the root cause.Historical trend has shown that this failure mode may also occur due to the design when multiple activation occurs.Instructions for use specify that to activate applicator it needs to be squeezed gently ¿only once¿.If the applicator was pinched several times this could be the probable cause for the failure mode.We will continue to track and trend for this failure mode.At this moment, no further action will be taken since a definite root cause could not be established.

• 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: 11625620
• MDR Text Key: 260981394
• Report Number: 3004932373-2021-00171
• Device Sequence Number: 1
• Product Code: KXG
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 270449
• Device Lot Number: 8264564
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR