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

Catalog Number 270299

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

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.: 270299, batch no.: 0078814.It was reported there was a hair inside of the packaging.

Manufacturer Narrative

Samples and photos were available for evaluation.Visual examination of the returned samples and photos showed a hair strain within the packaging.This verified the reported issue.The most probable root cause is the hair came from an operator during the packaging process.Production record review was completed for batch/lot: 0078814 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 issue.Records reviewed indicate that the lot passed all the in-process inspections.Awareness training was provided to associated related to frepp packaging.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported there was a hair inside of the packaging.Per product complaint form.Hair inside of packaging.

• Brand Name: CHLORAPREP ONE-STEP
• 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: 11327652
• MDR Text Key: 243895035
• Report Number: 3004932373-2021-00052
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 270299
• Device Lot Number: 0078814
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 04/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other