MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IMPREGNATED PREOPERATIVE SCRUB BRUSHES (4% CHG); CHLORAHEXIDINE GLUCONATE SOLUTION

Catalog Number 377479

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

Pr 4127874 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect: (b)(4).Imdrf annex f code health effect: (b)(4).Imdrf annex a code medical device problem code: (b)(4).Device or use problem: (b)(4).

Event Description

Material no.: 377479.Batch no.: unknown.It was reported that employee had a red patch that appeared on his skin after cleaning his hands and arms with bd chlorhexidine gluconate sponges.Verbatim: srg ip recently, we have an employee ((b)(6) cc here) who indicated to us that he had a red patch that appeared on his skin (on his arm).He cleaned his hands and arms with bd chlorhexidine gluconate sponges (product 377479).He didn't scrub his arm more intensely than elsewhere.

• Brand Name: IMPREGNATED PREOPERATIVE SCRUB BRUSHES (4% CHG)
• Type of Device: CHLORAHEXIDINE GLUCONATE SOLUTION
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: anna wehrheim ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13091164
• MDR Text Key: 288282072
• Report Number: 1710034-2021-01081
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 377479
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other