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

Catalog Number 930480NSB

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/11/2021

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 by the distributor that the sponges are falling off of the plastic applicator inside the packaging.Per email: hello bd product complaints, please see attached pdf notification for our discovery of 17 each defective components 930480nsb chloraprep applicator 1ml, lot #1127679.These items were delivered 06/11/21 from po 152451 line 50.Our production team found during mai kit assembly that the chloraprep sponges are not secure to base of chloraprep plastic body and are falling off, loose pieces in the shipment bags.Please see pdf photos for condition as found.The assembly team sorted material at the line and scrapped the chloraprep pieces to the mai work order, 17 each recorded.No additional stock of lot 1127679 in inventory to perform ansi sampling, no material on hold.6 each have been retained and given to qa as samples.Please let us know if you would like the samples returned to your attention.I would be glad to address any questions as best i can.Production team found during work order assembly that chloraprep sponge is not glued to base of chloraprep and falling off, loose in vendor bag.Assembly team sorted material at the line and scrapping chloraprep in pieces.17 each recorded.No additional stock of lot 1127679 in inventory to perform ansi sampling, no material on hold.6 each retained and given to qa as samples.

Manufacturer Narrative

Photos and samples were returned for evaluation.Visual examination shows the applicators without welded foams.During the manufacturing of the lot the welder energy was adjusted but adjustments were made within validated parameters.There was nothing found during the investigation to establish a definitive root cause.At this point, there is no adverse trend observed.A production batch history records for applicator pn 930480nsb lot number 1127679 were 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.Records reviewed indicate that the lot passed all the in-process inspections.No further action is required at this time.This failure will continue to be tracked and trended.

Event Description

It was reported by the distributor that the sponges are falling off of the plastic applicator inside the packaging.Per email: hello bd product complaints, please see attached pdf notification for our discovery of 17 each defective components 930480nsb chloraprep applicator 1ml, lot #1127679.These items were delivered 06/11/21 from po 152451 line 50.Our production team found during mai kit assembly that the chloraprep sponges are not secure to base of chloraprep plastic body and are falling off, loose pieces in the shipment bags.Please see pdf photos for condition as found.The assembly team sorted material at the line and scrapped the chloraprep pieces to the mai work order, 17 each recorded.No additional stock of lot 1127679 in inventory to perform ansi sampling, no material on hold.6 each have been retained and given to qa as samples.Please let us know if you would like the samples returned to your attention.I would be glad to address any questions as best i can.Production team found during work order assembly that chloraprep sponge is not glued to base of chloraprep and falling off, loose in vendor bag.Assembly team sorted material at the line and scrapping chloraprep in pieces.17 each recorded.No additional stock of lot 1127679 in inventory to perform ansi sampling, no material on hold.6 each retained and given to qa as samples.

• 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: 12264637
• MDR Text Key: 268129227
• Report Number: 3004932373-2021-00354
• 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
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 04/30/2024
• Device Catalogue Number: 930480NSB
• Device Lot Number: 1127679
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other