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	10/25/2024
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.
Event or Problem Description
It was reported that bd insyte autog bc wing needle did not completely retract.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.No impact to patient.No serious injury to hcp.(b)(6)2024 no samples, just the lot number that was involved that i sent in the initial information.No medications given in the start of the iv.Yes, button was depressed.The button appeared to get stuck and leave a portion of the needle exposed.The needle did retract, not fully.No needle stick injuries reported.Yes, button was depressed.The button appeared to get stuck and leave a portion of the needle exposed.(b)(6) yes, button was depressed.The button appeared to get stuck and leave a portion of the needle exposed.This is considered a partial retraction where the needle did not fully retract.How many times did this occur and with how many patients? approximately 15 or more times.Is there a specific date this occurred on? (b)(6)2024.The needle did retract, not fully.No needle stick injuries reported.Answers are the same as above.This is considered slow retraction where the needle did fully retract but was slow to do so.How many times did this occur and with how many patients? is there a specific date this occurred on? as a photograph of the top web label was provided, do you have any actual or representative samples that can be sent for evaluation?.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo which displayed the top web label of a 20ga x 1.00in.Insyte autoguard bc winged unit from lot number 4222721.The photo does not display any unit.The photograph provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause as it only displayed the top web label.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identity the root cause.
Event or Problem Description
No additional information.
Event or Problem Description
Customer response on (b)(6) 2025 we need some additional clarification regarding the dates provided in the previous responses: (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
Correction: aware date incorrect in the initial mdr.Additional information: event date confirmed.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo of two 20ga x 1.00in.Insyte autoguard bc winged units from lot number 4222721.The photo does not display any unit.The photograph provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause as it only displayed the top web label.A device history record review showed no non-conformances associated with this issue during the production of these batches.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
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: 21020448
• Report Number: 1710034-2024-01530
• Device Sequence Number: 3969726
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,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: 11/06/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/17/2025; 06/13/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/15/2025; 01/21/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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