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

Catalog Number 260100

Device Problems Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)

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

Event Date 02/23/2021

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

It was reported the lot number on the box does not match with the lot number on the product inside.Per complaint form: their (b)(6) fixed site reported the box lot# was different from the lot# of the chloraprep pouches inside of the box bd# 260100.The box had lot# 0300938, and the chloraprep pouches inside of the box had lot# 0300638.These were new boxes of the chloraprep item# 260100.They have a total of 7 boxes with the lot number wrong on the outside.They have been quarantined awaiting word from us.The customer has provided a picture: box shows 0300938, the foil package is imprinted with 0300638, both have 10/22 as expiration date.Warehouse reported the info below: "we received lot #0300638 in december of 2020.Warehouse has no record of ever receiving a lot #0300938.Lot #0300638 have all been kitted so i don't have the outer cases anymore.We do have 4 orange boxes that have lot #0300938 written on the outside but have lot #0300638 on the packages inside.".

Manufacturer Narrative

Samples and a photo were available for evaluation.Samples and the photo were analyzed and indeed the inner carton has the incorrect lot number stamped verifying the reported issue.A rubber stamp is used during manufacturing to stamp the lot number and the expiration date manually unto the inner cartons.The most probable cause is that during the manufacturing of the lot, one of the associates corrected the lot number on the rubber stamp used to stamp the inner cartons.It is possible the quality group was not notified that there were changes to the stamp.This may have happened because either the stamp was not found or available and a new stamp was used and therefore it was setup again for the lot that was being manufactured.If quality was not notified of this change the setup of the stamped could have been done incorrectly.A production record review was completed for 0300638 and no defect were found during routine in-process inspections.An awareness training has been imparted to all associates and qa technicians to make them aware that if there are changes to the stamps, quality must be notified, and a verification must take place.A change control will be opened to add a statement to the manufacturing instructions for swabsticks that if there are any changes to the stamp during the shift, quality must be notified and there needs to be a verification.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported the lot number on the box does not match with the lot number on the product inside.Per complaint form: their portland oregon fixed site reported the box lot# was different from the lot# of the chloraprep pouches inside of the box bd# 260100.The box had lot# 0300938, and the chloraprep pouches inside of the box had lot# 0300638.These were new boxes of the chloraprep item# 260100.They have a total of 7 boxes with the lot number wrong on the outside.They have been quarantined awaiting word from us.The customer has provided a picture: box shows 0300938, the foil package is imprinted with 0300638, both have 10/22 as expiration date.Warehouse reported the info below: "we received lot #0300638 in december of 2020.Packing slip is attached.Warehouse has no record of ever receiving a lot #0300938.Lot #0300638 have all been kitted so i don't have the outer cases anymore.We do have 4 orange boxes that have lot #0300938 written on the outside but have lot #0300638 on the packages inside.".

• Brand Name: CHLORAPREP SWABSTICK
• 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: 11628757
• MDR Text Key: 266496883
• Report Number: 3004932373-2021-00180
• Device Sequence Number: 1
• Product Code: KXG
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 260100
• Device Lot Number: 0300638
• Date Manufacturer Received: 06/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other