MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381833
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	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: a follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autoguard foreign matter found on needle.The following information was provided by the initial reporter, translated from french to english date of occurrence: on (b)(6) 2024.Incident description: while handling the mandrel, a suspicious blackening was spotted on the canula as well as on the catheter adapter.Current patient condition: no direct consequences for the patient, problem identified before use.Risk of iatrogenia if contamination of the batch is confirmed.Actions taken in the care facility to manage the patient: use of another device.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed an unsealed 20ga x 1.00in.Insyte autoguard unit.The photos display some black foreign matter on the button of the device and on the cannula near the notch.Your reported issue was confirmed.Although your reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing foreign matter may have been introduced during packaging or manufacturing as a result of environmental factors, incoming material, or personnel.To mitigate the occurrence of these defects: operators perform cleaning per the quality plan and the bd 5s initiative, good manufacturing practices and gowning are followed, and environmental controls and inspections for foreign matter are performed per the quality control and sampling plans.The photos display the unit unsealed and uncovered so it is unclear when this foreign matter was introduced.The physical sample would need to be provided for further investigation.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 20367440
• Report Number: 1710034-2024-01115
• Device Sequence Number: 15170678
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334(11)240425(17)270331(10)4116187
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: Other
• Device Catalogue Number: 381833
• Device Lot Number: 4116187
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown