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

Catalog Number	382633
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd.The following information was provided by the initial reporter: i'm reaching out to report a malfunction with a device we have at our facility.It is the bd insyte auto guard 20 g x 1.00 in.The needle is slow to retract or will not retract completely leaving the needle exposed for a potential needlestick.I will attach the picture that has the identifiers on it.They have seemed to be contained to the same lot right now.The lot #4222721.Item ¿ 382633.Customer response october 31, 2024: 1) no impact to patient.2) no serious injury to hcp.3) (b)(6) 2024.4) no samples, just the lot number that was involved that i sent in the initial information.5) no medications given in the start of the iv.6) yes, button was depressed.The button appeared to get stuck and leave a portion of the needle exposed.7) the needle did retract, not fully.No needle stick injuries reported.Customer response: nov 6, 2024.6.(2) approximately 15 or more times.6.(3) (b)(6) 2024.#7 answers are the same as above.Customer response on jan 06, 2025.We need some additional clarification regarding the dates provided in the previous responses: (b)(6) 2024, (b)(6) 2024.Could you please confirm if these are four distinct dates when the events occurred, or if they represent approximate date ranges during which the events took place? events did occur on these dates.
Additional Manufacturer Narrative
This mdr is a result of additional information that was received that confirmed a 4th event date.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
Additional information of fa#.

• 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: 21179336
• Report Number: 1710034-2025-00026
• Device Sequence Number: 4222612
• Product Code: FOZ
• UDI-Device Identifier: 00382903826339
• UDI-Public: (01)00382903826339(11)240815(17)270731(10)4222721
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 382633
• Device Lot Number: 4222721
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-25-5274
• Patient Sequence Number: 1
• Patient Sex: Unknown