MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 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	07/23/2025
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.The following information was provided by the initial reporter: we were conducting dv testing at bdti using the 20 ga x 1.00 inch iag bc winged product, (sku 382633, lot 5149270) and the needle of one of our samples did not retract when the button was pressed.Continued button pressing did not cause the needle to retract.
Additional Manufacturer Narrative
Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.However, the reported defect of needle retraction failure is confirmed since a trend has been identified for the reported failure mode and corrective actions have been initiated to investigate this type of incident and identify the root cause.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No additional information.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.Bd received one 20g insyte autoguard unit from lot number 5149270.Your report that the needle did not fully retract when the safety mechanism was activated was confirmed and the cause appeared to be manufacturing related.The needle was received partially retracted.The needle hub was caught on a deformed edge of the grip inside the safety shield at the overlapping junction with the barrel.It appeared that the safety mechanism was able to be activated; however, the damage prevented the needle from fully retracting.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.

• Brand Name: 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: 22753885
• Report Number: 1710034-2025-01313
• Device Sequence Number: 13102378
• Product Code: FOZ
• UDI-Device Identifier: 00382903826339
• UDI-Public: (01)00382903826339(17)280430(10)5149270
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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: 5149270
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 09/29/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown