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 Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the sales representative that there was no dye in the applicator.

Event Description

Material no.: 930815 batch no.: 1089896 it was reported by the sales representative that there was no dye in the applicator.Per complaint form: a staff member turned in a chloraprep because when they went to use it there was no orange dye, but just the liquid came out.

Manufacturer Narrative

Photos were provided and bd was able to confirm the failure mode.The batch record for pn 930815 ln 1089896 was reviewed and there were no non-conformances related to "missing pledget" during the manufacturing of this lot.Furthermore, the maintenance logbook was reviewed as well and there were no issues reported with the function of the pledget presence sensor during the manufacturing of the lot.It is most probable that the sensor did not function correctly and failed to alert the absence of the pledget in the applicator.

• 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 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 12337887
• MDR Text Key: 267136145
• Report Number: 3004932373-2021-00399
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 930815
• Device Lot Number: 1089896
• Date Manufacturer Received: 10/12/2021
• Patient Sequence Number: 1