MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP UNKNOWN; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270449

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Material no.: unknown, batch no.: unknown.It was reported the chloraprep applicator caused a small abrasion to a child's skin possibly due to shard of glass.Per bd website query: business unit: specimen collection product line: enquiry: used a chloraprep stick to clean a child's skin which resulted in a small abrasion to the skin, possibly caused by a shard of glass from the stick.Site: (b)(4).

Event Description

It was reported the chloraprep applicator caused a small abrasion to a child's skin possibly due to shard of glass.Per bd website query: business unit: specimen collection product line: enquiry: used a chloraprep stick to clean a child's skin which resulted in a small abrasion to the skin, possibly caused by a shard of glass from the stick.Site: united kingdom.

Manufacturer Narrative

Photos are now available for evaluation.Visual examination of the photos did not show clearly the exact point where the glass protruded from.Unfortunately, as a result, bd was unable to verify the reported issue or define a root cause at this time.Current process failure mode and effects analysis refers incorrect placement of foam or incorrect gluing of foam as a possible process failure mode, but in the pictures provided, the foam appears to be in its place.Historical trend has shown that this failure mode may 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.Production record review has been completed for batch/lot 8331739 and no non-conformances we're noted during the manufacturing of this lot.No further action is required.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11300699
• MDR Text Key: 230968079
• Report Number: 3004932373-2021-00046
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• 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: 06/09/2021

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: 11/30/2021
• Device Catalogue Number: 270449
• Device Lot Number: 8331739
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR