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

Catalog Number 930815

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that the seams of the packages were not glued well.

Manufacturer Narrative

Two photos were received by our quality team for evaluation.Upon visual inspection, it was observed that there was red tape showing (open seal) on package; therefore, the incident could be verified.The red tape affects the sealing integrity of the package because it¿s used to annex two rolls of packaging material.If a sample has an open seal, the defect would be self-announcing and easily detectable by the customer due to the visible red tape.A device history record could not be evaluated as the lot number is unknown.Based on the investigation, the most probable root cause is the lidding splice performed at incorrect location by operator not prior to red tape sensor.As part of routine production, when an ending roll must be joined to a new roll the union splice is taped together with red tape to aid as a visual identification and for the vision system detection.The packaging machine has a red splice sensor which would detect the packages as nonconforming and would not cut them into individual packages preventing them from being packaged.However, this sensor is set up to detect roll splices from the supplier and not union splices performed by operations when connecting an ending roll to a new roll.Investigation found that in this instance during a change of lidding, the red tape union splice was placed after the red tape sensor as part of a union splice so it was not detected by the system and the operator in packaging side did not discard the affected packages.A change control was initiated for the splice sensor relocation to prevent inadvertent bypassing of the red tape sensor and there was no adverse trend observed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the seams of the packages were not glued well.

• Brand Name: CHLORAPREP ONE-STEP HI-LITE ORANGE
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11066222
• MDR Text Key: 224777929
• Report Number: 3004932373-2020-00160
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other