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 Material Separation (1562); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the top cap popped off and glass shards came out.

Manufacturer Narrative

Two activated applicators with no end cap for lot # 0328213 were received for analysis by our quality team.With the sample provided, bd was able to verify 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 verified 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.H3 other text : see narrative below.

Event Description

It was reported that the top cap popped off and glass shards came out.

• 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: 11353324
• MDR Text Key: 254392862
• Report Number: 3004932373-2021-00061
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 930815
• Device Lot Number: 0328213
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other