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

Catalog Number	382612
Medical Device Problem Codes	Retraction Problem (1536); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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 insyte autog bc wing needle was slow to retract when testing device.The following information was provided by the initial reporter:¿ needle did not retract promptly, and catheter would not thread off needle when inserting peripheral iv.There is a significant glitch when pressing the retract button.I had to pull the needle all the way out, exposed, before it would retract.I tested a couple others with the same lot number; they were slow to retract.¿ kindly provide the date of event.(b)(6) 2025 any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.None to my knowledge.
Event or Problem Description
Is there any issue with this material #381412.Lot: 4292347 i opened several with the lot.They retracted with no issues.The catheter surfaces are not smooth near the tip.
Additional Manufacturer Narrative
Correction: event update to change as reported code to needle & catheter tip integrity as customer stated in follow up that catheter tip is not smooth.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs and samples submitted for evaluation.The report of delayed needle retraction was confirmed, and the cause appeared to be manufacturing related.Used and unused 24g insyte autoguard units were provided for investigation from lot #4292347.Two photographs were also provided for investigation.A functional test of the used samples revealed no damage or defects.A functional test of the unused representative samples revealed retraction times that exceeded the specification.The delayed retraction appeared to be associated with dispersed gel between the flash chamber and the grip.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure of retraction issues and corrective actions have been initiated to investigate this type of incident and identity the root cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
No additional information.

• 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: 22119570
• Report Number: 1710034-2025-00925
• Device Sequence Number: 4122475
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided; 07/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/28/2025
• 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