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

Catalog Number	382634
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Insufficient Information (4580)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the date received by manufacturer has been used for this field.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 autog bc wing needle was slow to retract leading to blood leak.The following information was provided by the initial reporter: needle sluggish when retracting during safety allowing blood to leak from hub.
Additional Manufacturer Narrative
Material information and annex codes updated.Investigation results: our quality engineer inspected the sample submitted for evaluation.Your report of slow needle retraction could not be confirmed from the returned sample.One insyte autoguard needle from lot number 4150600 was provided for investigation.The needle was received fully retracted.A functional test showed that the needle retracted within specification.The condition of the returned device may prevent confirmation of the reported issue.Once the needle fully retracts, the reported issue may not be possible to replicate.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure of retraction issues and corrective actions have been initiated to investigate this type of incident and identity the root cause.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOG BC WING
• 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: 22047468
• Report Number: 1710034-2025-00871
• Device Sequence Number: 18390004
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346(11)240529(17)270531(10)4150600
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 382634
• Device Lot Number: 4150600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown