MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO; PERIPHERAL IV CATHETERS

Catalog Number	392533
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd iag bc pro appears to have rust on the inside of the catheter.The following information was provided by the initial reporter: rcc received a complaint via phone.Issue1: looks like it has rusting on the inside of the catheter.Sample available pt impact: no.Doe: unknown.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 392533 and lot number 3181567.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Complaints received for this device and reported condition will continue to be tracked and trended.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bds notification (reference fda document number (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family - insyte autoguard bc.Device failure - rust or corrosion.
Event or Problem Description
No additional information.

• Brand Name: BD IAG BC PRO
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18394678
• Report Number: 1710034-2023-01478
• Device Sequence Number: 8619161
• Product Code: FOZ
• UDI-Device Identifier: 00382903925339
• UDI-Public: (01)00382903925339
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 392533
• Device Lot Number: 3181567
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 03/22/2024; Not provided
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 04/01/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown