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

Catalog Number	382557
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 382557 and lot number 4002491.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.Based on the available information, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd insyte autog bc needle was slow to retract.The following information was provided by the initial reporter: safety malfunction response on (b)(6) 2025 could you please provide a further description of the issue? slow retraction/ retraction button getting stuck what was the impact to the patient? no harm.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? during use can you please provide an exact date of event? unknown.

• Brand Name: BD INSYTE AUTOG BC
• 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: 21472072
• Report Number: 1710034-2025-00321
• Device Sequence Number: 21020132
• Product Code: FOZ
• UDI-Device Identifier: 00382903825578
• UDI-Public: (01)00382903825578(11)240102(17)261231(10)4002491
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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 Catalogue Number: 382557
• Device Lot Number: 4002491
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown