MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 BD E-Z SCRUB; IMPREGNATED PREOPERATIVE SCRUB BRUSHES (WITH 4% CHG)

Catalog Number 371073

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The staff of the centrum warehouse of the central military hospital when taking out surgical brushes with chlorexidine and placing them on their shelf realizes that 4 pieces are leaking solution.

Manufacturer Narrative

Root cause cannot be determined from the manufacturing investigation.Batch record did not note any discrepancies or deviations that would attribute to this issue.Risk level is low as defect of inadequate seal integrity (e.G., leaking units) is easily detectable by the end user and has a low severity rating.Complaints will continue to be trended and evaluated for further action, if needed.No capa required.

Event Description

The staff of the centrum warehouse of the central military hospital when taking out surgical brushes with chlorexidine and placing them on their shelf realizes that 4 pieces are leaking solution.Information received on 10.25.2021: the batch number is 1029722.

• Brand Name: BD E-Z SCRUB
• Type of Device: IMPREGNATED PREOPERATIVE SCRUB BRUSHES (WITH 4% CHG)
• 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: 12571594
• MDR Text Key: 274598119
• Report Number: 3004932373-2021-00455
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 371073
• Device Lot Number: 1029722
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other