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

Catalog Number	382612
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc wing needle was slow to retract.The following information was provided by the initial reporter: when problem was notice: during use sterilization wrap: incident discovered during patient care: no.Date of event: 2/27/2025 12:00:00 am.Incident details: when the safety is engaged, it either retracts in slow motion, or sometimes gets stuck and the needle is not able to retract.Was patient or end-user injured: no.Was medical treatment required: no.Patient current status: n/a.Thu (b)(6) 2025 8:29 am 1.Were there 7 patients in total? i don¿t have an exact number of patients effected.This happened at multiple sites over a span of several months before we were able to identify the lot number.2.How many different patients were for a retraction failure and how many were for a slow retraction? i don¿t have exact numbers.3.Did all occurrences occur on (b)(6) 2025? no, this happened for several months prior to it being reported.It happened at multiple locations including (b)(6).My responses are the same as ***.This was happening on several occasions over the course of weeks to months.I had 4 incidents reported to me before the lot number was identified.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the samples submitted for evaluation.Your report of slow needle retraction was confirmed and the cause appeared to be manufacturing related.Used and unused 24g insyte autoguard units from lot #4292347 were provided for investigation.A functional test revealed that the needles fully retracted; however, the retraction time of some unused samples exceeded the 1.5 second requirement.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: 21668131
• Report Number: 1710034-2025-00457
• Device Sequence Number: 14571652
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124(11)241018(17)270930(10)4292347
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 382612
• Device Lot Number: 4292347
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown