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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the back end of the applicator fell off and the glass cut the operator.Ampule was cracked for prep and back end cap came off, spilling the glass.Patient was not harmed but reported that tech got small cut from glass.

Manufacturer Narrative

The facility did not provide any samples or photos to evaluate for the investigation.Unfortunately, as a result, bd was unable to verify the reported issue.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.The root cause is attributed to the equipment station for the end cap placement unto the applicator body.Production record review has been completed for the batch/lot 0339071 and no non-conformance were noted during the manufacturing of this lot.Corrective actions were initiated which led to bd conducting a voluntary recall on certain lots of the chloraprep hi-lite orange 26 ml applicator.Your facility should have received a recall notification for this failure, and it also attached to this email.Please ensure that your facility completes the customer response form associated with the recall and follow the directions provided.Bd recognizes that customers place their trust in our products, and we strive to exceed the expectations of every customer.Your feedback is essential to our mission to improve the productivity and safety of health care globally.

Event Description

It was reported the back end of the applicator fell off and the glass cut the operator.Ampule was cracked for prep and back end cap came off, spilling the glass.Patient was not harmed but reported that tech got small cut from glass.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11330527
• MDR Text Key: 238611032
• Report Number: 3004932373-2021-00054
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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: 930815
• Device Lot Number: 0339071
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other