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

Catalog Number	392623
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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.E1: address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd iag bc pro wing needle was slow to retract.The following information was provided by the initial reporter: customer responded on (b)(6) 2025, stating the additional devices received experienced the same issue of ¿needle retraction slow¿.They did not provide an event date.Event description: it was reported by customer that push button on iagbc is significantly delayed in retracting the needle, risking needle stick to the nurse.21 jan: the event first occurred on january 7, 2025, however it has occurred multiple times.No staff harm at this point however the potential is still there with the needle not retracting.
Additional Manufacturer Narrative
Investigation results: the complaint of a delayed retraction could not be confirmed from the 3 representative 22ga insyte autoguard bc pro winged units that were received in sealed packaging from lot: 3207476.A functional test revealed that each needle retracted within the specification limit.No damage or defects associated with the manufacturing process were identified on the returned sample.However, a trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identify the root cause.Although the representative samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.

• Brand Name: BD IAG BC PRO 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: 21258675
• Report Number: 1710034-2025-00084
• Device Sequence Number: 8075685
• Product Code: FOZ
• UDI-Device Identifier: 00382903926237
• UDI-Public: (01)00382903926237(11)230731(17)260630(10)3207476
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/02/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 392623
• Device Lot Number: 3207476
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown