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

Catalog Number	381911
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n autoguard winged hub thread is damaged.The following information was provided by the initial reporter: date of incident: (b)(6) 2024.Type of incident/problem: connection problem.Level of harm: no apparent harm - reached patient/person, inconvenient.Incident details: peripheral iv cannula was inserted successfully and upon the inserter attempting to connect the cannula to the extension set the luer would not thread.Visual inspection of the cannula shows that one section of the threads appears to have either extra plastic or crushed/flattened on one side.Impact of incident: baby needed an additional poke for piv insertion despite successful insertion on first attempt.
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.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one 24g insyte-n autoguard winged iv catheter from lot number 3341473.A visual and microscopic examination revealed a deformed adapter at the thread.The material was partially sheared but remained intact.A functional test showed that a luer lock syringe could not be attached to the adapter; however, a 3-way stopcock with a luer lock rotating collar could be attached to the deformed adapter.The damage observed on the adapter likely occurred during manufacturing due to a misalignment and/or gripper damage.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE-N AUTOGUARD WINGED
• 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: 19600467
• Report Number: 1710034-2024-00641
• Device Sequence Number: 15474904
• Product Code: FOZ
• UDI-Device Identifier: 00382903819119
• UDI-Public: (01)00382903819119
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: Health Professional
• Device Catalogue Number: 381911
• Device Lot Number: 3341473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown