MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4 PRCT CHG SCRUB BRUSH; CHLORAHEXIDINE GLUCONATE SOLUTION

Catalog Number 371073

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Personnel at the time of dispensing detect liquid spillage.

Event Description

Personnel at the time of dispensing detect liquid spillage.

Manufacturer Narrative

Review of dhr did not find any attributable deficiencies that would lead to this issue.Review of risk management document shows that leaking seal is an acceptable risk with an occasional occurrence and minor severity for this defect.And customer dissatisfaction or patient infections/complications being the potential failure mode.Review of the batch record shows that production was performed as specified and all in-process quality checks met established specifications.Review of lot history show no non-conformance events issued for this lot.Root cause for this issue cannot be established at this time.Any future complaints will continue to be monitored for this lot and assessed.H3 other text : see below.

• Brand Name: 4 PRCT CHG SCRUB BRUSH
• 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: 12971125
• MDR Text Key: 287119921
• Report Number: 1710034-2021-01041
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 371073
• Device Lot Number: 1161355
• Date Manufacturer Received: 01/05/2022
• 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