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

Catalog Number	382634
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
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.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd insyte autog bc wing needle retraction failure.The following information was provided by the initial reporter: 20 gauge needles - nurses have noticed difficulty in the needles not retracting back in once they have been used.When they push the button to retrack the needle, the needle gets stuck and they have to use their finger to assist it to retract.Even though they push the button multiple times it does not retract.However when they tested a needle that has not been used on a patient, the needle retracts as designed.This issue may be related to the lot, but it only occurs when used on a patient.They have said they do not have issues on the 22 gauge needles.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle gets stuck during retraction was confirmed from the circumstantial evidence that was observed in a provided photo.One of the returned photos showed the needle protruding through the side of the catheter tubing.The needle was partially retracted, but the needle remained extended from the safety shield.No other damage or defects were identified on the images or videos that were provided for investigation.Due to the evidence of use, the damage likely occurred during the insertion procedure.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
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: 21060531
• Report Number: 1710034-2024-01566
• Device Sequence Number: 15492072
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346(11)240119(17)261231(10)4012522
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 4012522
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown