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

Catalog Number 260400NS

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that the label print is misaligned and the impression is inadequate.Per complaint details: nonconformance description: during packaging of order (b)(4), manufacturing department reported to found 35 pieces of material u-45703-002 batch 13p20h0445 with inadequate impression of 'information of use' on the lidstock of the chloraprep.(some chlorapreps have illegible text).

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo shows the root cause of the condition appears to be that the lidding (tip web) was out of registration with respect to the rest of the package.This verified the reported issue.A device history review did not show that any in-process non-conformances, or that process adjustments were required during the manufacturing of this lot.The lot was released by passing all qa inspections.Trend analysis shows that no other incidents have been reported for pn 260400ns lot 0191859.This appears to have been an isolated occurrence.An awareness training was performed involving all 3ml packaging associated and to the qa technicians.No further action is planned at this time.This failure mode will continue to be tracked and trended.H3 other text: see narrative below.

Event Description

It was reported that the label print is misaligned and the impression is inadequate.Per attached complaint details: nonconformance description: during packaging of order 3012711, manufacturing department reported to found 35 pieces of material u-45703-002, batch 13p20h0445 with inadequate impression of 'information of use' on the lidstock of the chloraprep.(some chlorapreps have ilegible text).

• 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: 11628200
• MDR Text Key: 247780992
• Report Number: 3004932373-2021-00178
• 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: 06/21/2021

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: 06/30/2023
• Device Catalogue Number: 260400NS
• Device Lot Number: 0191859
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other