MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP UNKNOWN; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Your facility did not provided photos or samples to aid in our quality engineer's investigation.Unfortunately, without the sample, bd was unable to verify the reported issue.Production record review could not be completed as the batch/lot of the defective product was unknown.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 may have included this lot, had an applicator end cap that was improperly secured during the manufacturing process.Your facility should have received a recall notification for this failure, and it is also attached to this email.Please ensure that your facility completes the customer response form associated with the recall and follows 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 by the sales representative that the end cap fell off the applicator during use.Per complaint form: was notified by a nurse that the end cap of a 26ml chloraprep applicator was defective and came off while prepping the patient.The applicator was throw away, so the applicator is not available for return.The charge nurse said that there was another applicator that did the same thing the week before.Staff is aware to keep future applicators so lot numbers can be recorded and sent in to bd.

• Brand Name: CHLORAPREP UNKNOWN
• 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: 11991616
• MDR Text Key: 268135257
• Report Number: 3004932373-2021-00281
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other