MAUDE Adverse Event Report: CHLORAPREP ONE STEP HI-LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 261815

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They report that during the manufacturing process they find 6 pieces that present foreign particles on the sponges.Foreign particles: (b)(4).Spots/dots: (b)(4).

Manufacturer Narrative

Photos were available for evaluation.Visual examination of the photos shows foreign material on the sponge of the applicators pictured.This verified the reported issue.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the packaging of the product such cleaning activities.The production record review was completed for batch/lot 0170675 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.

Event Description

They report that during the manufacturing process they find 6 pieces that present foreign particles on the sponges.___ foreign particles: pr# (b)(4).Spots/dots: pr# (b)(4).*** additional information received on 10/07/2021: of the 6 pieces: 5 pieces with foreign particles and 1 piece with spots.****.

• Brand Name: CHLORAPREP ONE STEP HI-LITE ORANGE
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• MDR Report Key: 12569064
• MDR Text Key: 274522311
• Report Number: 3004932373-2021-00454
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 261815
• Device Lot Number: 0170675
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other