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 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Imdrf annex e code health effect ¿ clinical code: e2403 no clinical signs, symptoms or conditions imdrf annex f code health effect ¿ impact code: f27 no patient involvement or f27 imdrf annex a code medical device problem code: a0501 detachment of device or device component (2907) pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Hold kd material no.: 930815, batch no.: 0328213.It was reported by the health professional that the end cap fell off and the glass fragments fell on the patient.

Event Description

It was reported by the health professional that the end cap fell off and the glass fragments fell on the patient.

Manufacturer Narrative

The facility did not provide photos/samples to aid in our quality engineer¿s investigation.With the lack of sample provided, bd was unable 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.Although the complaint could not be confirmed, 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.

• 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: 12178781
• MDR Text Key: 261923020
• Report Number: 3004932373-2021-00331
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 0328213
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other