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

Catalog Number 930800

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

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

Material no.: 930800; batch no.: 9347111.It was reported that the applicators without solution inside.Per rep response email: i've provided further clarification on the below questions.How many devices were affected? about 3, that i'm aware of.On what date was the reported issue first discovered? (b)(6) 2020.Are the physical devices available to be sent in for evaluation? yes.Was there any evidence of the ampoule broken such as broken glass shards seen when held up to a light or heard when shaking? no, it just appears like there are no ampoules in the applicators at all.Per email: i'd like to report a product complaint.My customer reported that they received several chlora-prep applicators witb5.Hout solution inside.Photos from the customer are attached to this email, and additional relevant information is below.Thank you! bd item#: 930800; lot#9347111.Received the complaint on 10/21/2020.No harm to the patient, treatment, or procedure.

Event Description

Material no.: 930800.Batch no.: 9347111.It was reported that the applicators without solution inside.Per rep response email: i¿ve provided further clarification on the questions.

Manufacturer Narrative

Photos were received for evaluation.Visual examination of the photos show the applicator or inside the original unopened package.The ampoules can not be observed due to the thick opaque plastic body of the applicator and the ampoules may be missing.For this customer complaint, the ampoules will be assumed as missing, verifying the failure mode.The product is assembled on an automated machine cavity and confirms the ampoule presence by sensors.The ampoule sensors are cleaned and tested as part of the preventative maintenance procedure.The root cause is deemed to be a malfunction of the assembly equipment during the manufacturing process.Product record review was completed with lot 9347111 and no non-conformance was noted during the manufacturing of this lot.No further actions are required at this time.The failure mode will continue to be tracked and trended.

• 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: 10853478
• MDR Text Key: 216952082
• Report Number: 3004932373-2020-00128
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: 01/30/2022
• Device Catalogue Number: 930800
• Device Lot Number: 9347111
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 01/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other