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

Catalog Number 930715

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 01/27/2021

Event Type  Injury  

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.: 930715, batch no.: 0327923.It was reported glass shards came out of the applicator post-activation and cut the user.Per email: i have called your customer service number (800-523-0502) to report an issue that we had with the bd chloroprep hilite orange 10.5ml applicator.When i tried to follow up a short time ago, i was disconnected twice.This morning a surgical tech at our facility reported that some glass shards came out of the applicator after she activated it.These shards not only contaminated the sterile field, but also caused several cuts to her fingers.I am concerned about using more products, especially those from that lot because i do not want any further injury to my staff.I also do not wish to cause additional cost and work of reprocessing the instruments and items contaminated.Have you had any other issues reported with this item? the lot # is 327923, exp 11/23.Please let me know how my staff can regain confidence in the use of your product.Please have someone contact me as soon as possible regarding this issue.

Event Description

It was reported glass shards came out of the applicator post-activation and cut the user.Per customer response email: after further investigation, i have discovered that the surgical tech did not activate the chloroprep.It was & remains intact.When it was opened from the outer packaging, the shards of glass went everywhere, contaminating the field.Her injuries were minor (thankfully) and i believe are all healed.Per email: i have called your customer service number ((b)(6)) to report an issue that we had with the bd chloroprep hilite orange 10.5ml applicator.When i tried to follow up a short time ago, i was disconnected twice.This morning a surgical tech at our facility reported that some glass shards came out of the applicator after she activated it.These shards not only contaminated the sterile field, but also caused several cuts to her fingers.I am concerned about using more products, especially those from that lot because i do not want any further injury to my staff.I also do not wish to cause additional cost and work of reprocessing the instruments and items contaminated.

Manufacturer Narrative

Two samples were received for evaluation.Visual examination of the two conforming applicators were received without the original unopened packed with lot number 327923 11/23 printed on body (ampoule intact (unactivated)/solution inside ampoule) no open weld or glass puncturing thru applicator wall handle, no visible glass or defect noted (conforming).As a result, bd was unable to verify the reported issue or defined a probable root cause.Production record review was completed for batch/lot 0327923 and no non-conformances were identified during the manufacturing of this lot.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text: see narrative below.

• 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: 11296644
• MDR Text Key: 230968659
• Report Number: 3004932373-2021-00044
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 930715
• Device Lot Number: 0327923
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other