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

Catalog Number 930599NSB

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

Patient Problem Abrasion (1689)

Event Date 03/25/2021

Event Type  Injury  

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 use.

Event Description

Material no.: 930599nsb, batch no.: 0160547.It was reported that glass shards came out of the chloraprep applicator and cut a patient.Per scar: received customer complaint that glass shard were coming out of one of the chloraprep applicators and cut a patient.Customer is returning the sample if needed for evaluation.

Event Description

Material no.: 930599nsb batch no.: 0160547 it was reported that glass shards came out of the chloraprep applicator and cut a patient.Per scar: received customer complaint that glass shard were coming out of one of the chloraprep applicators and cut a patient.Customer is returning the sample if needed for evaluation.

Manufacturer Narrative

Pr 2659127 follow up emdr submission.Failure mode is not confirmed since defective sample was not delivered and no photos were provided by customer.Production batch history records for applicator material no.: 930599nsb 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.However some opportunities were found in the corrective maintenance of the filling ampoule equipment which potentially can produce broken ampoule.Corrective maintenance were performed to eliminate/decrease broken ampule failure mode.Awareness training regarding broken ampule was provided to production, engineering and quality associates.See narrative below.

• 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: 11625637
• MDR Text Key: 246560370
• Report Number: 3004932373-2021-00172
• 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: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

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: 05/31/2023
• Device Catalogue Number: 930599NSB
• Device Lot Number: 0160547
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR