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

Catalog Number 930815

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930815.Batch no.: 0327868.It was reported the end cap of the applicator fell off causing the glass to become exposed.Per email: please review and provide a response to the product quality issue reported.Please contact the facility directly for details, sample collection and resolution.When the investigation has completed, please provide the facility contact with a copy of the closure letter.This was reported to healthtrust as reporting purposes only, as such no follow up will be completed by member support.We will be closing this case on our end.[omitted] product catalog number: 930815.Product description: applicator 2% chg 70% isoprpnl 1 step apl 26ml orng hi-lt.Origin of the issue: product failure//design.Detail: the bottom is falling off applicator.Glass tube becomes exposed and could cause an injury.Not reported to vendor representative.Number of occurrences: 3.0.Sample available: true.Lot number: 0327868.

Manufacturer Narrative

The facility did provide photos/samples to aid in our quality engineer¿s investigation.With the sample, provided, bd was able to confirm the failure mode as the end cap was detached from the applicator body.A device history record was reviewed, and no non-conformances was noted during the manufacturing of this lot.The root cause is attributed to the equipment station for the end cap placement unto the applicator body.Corrective actions were initiated which led to bd conducting a voluntary recall on certain lots of the chloraprep hi- lite orange 26 ml applicator.Bd has confirmed that some of the product, which included this lot, had an applicator end cap that was improperly secured during the manufacturing process which resulted in broken glass dropping out of the applicator.

Event Description

It was reported the end cap of the applicator fell off causing the glass to become exposed.

• 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 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11499841
• MDR Text Key: 263931922
• Report Number: 1625685-2021-00023
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 930815
• Device Lot Number: 0327868
• Date Manufacturer Received: 06/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other