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

Catalog Number	382644
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.H.3.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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Material and batch information updated in d tab.Annex codes updated.Investigation results: our quality engineer inspected the samples submitted for evaluation.Your report of a retraction issue was confirmed from the returned sample; however, the root cause could not be determined.13 insyte autoguard needles were provided for complaints (b)(4).The samples exhibited evidence of use.The safety mechanism had been activated on each safety shield.All needles except one were received fully retracted within the shield.The bevel and tip of one needle extended beyond the grip.The barrel component of the safety shield was cracked and damaged, which prevented the needle hub from fully retracting.As the device has been opened and used, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.A functional test of the returned samples revealed no damage or defects with the safety mechanism and retraction time.The reported sluggish retraction and blood leak from hub could not be confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 22047772
• Report Number: 1710034-2025-00868
• Device Sequence Number: 8908733
• Product Code: FOZ
• UDI-Device Identifier: 00382903826445
• UDI-Public: (01)00382903826445(11)241029(17)270930(10)4299225
• 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): 07/30/2025

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 Catalogue Number: 382644
• Device Lot Number: 4299225
• 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: 07/30/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown