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

Catalog Number 930480NSB

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 11/25/2020

Event Type  Injury  

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 upon scrubbing the site, the foam pad came off and the glass shards exited the device onto the patients skin causing abraded cuts.

Manufacturer Narrative

Samples and a photo were received by our quality team for evaluation.Upon inspection of the sample, it was observed that the foam on the applicator was welded upside down; therefore, the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, the most probable root cause of the foam coming off the applicator during use was the incorrect orientation of the foam tip at the time of manufacturing.The foam welding onto the applicators consists of two parts.One part is foam and the other part is a thin novonette that is glued to the foam.The function of the novonette is to facilitate the welding of the foam to the plastic applicator.When assembled the 1ml applicators must have the foam positioned in such a way that the novonette of the foam is in contact with the plastic applicator.The sample shows that the unit was assembled with the foam upside down.Without the presence of the novonette between the foam and the plastic applicator the welding process was unsuccessful resulting on an open weld.To prevent this incident from happening, all 1ml assembly machines have two vision systems that ensure the proper orientation of the foam.If the foam is placed incorrectly the part is not welded and is removed from the assembly process.All sensors were checked on all three 1ml assembly machines and they were performing appropriately.Sensors are checked at the beginning of every shift as part of the setup process.An additional check during the creation of each lot has now been added to the manufacturing process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

Event Description

It was reported that upon scrubbing the site, the foam pad came off and the glass shards exited the device onto the patients skin causing abraded cuts.

• Brand Name: CHLORAPREP ONE-STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11005130
• MDR Text Key: 221467222
• Report Number: 3004932373-2020-00151
• Device Sequence Number: 1
• Product Code: KXF
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 930480NSB
• Device Lot Number: 0219708
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR