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

Catalog Number	392544
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd iag bc pro needle did not retract.The following information was provided by the initial reporter: once catheter was placed, rn attempted to activate safety mechanism to retract needle, but did not work.Rn removed needle completely from catheter, away from patient and attempted to retract needle with button, no success.The issue occurred on (b)(6) 2025.There was no harm to the patient.
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.
Additional Manufacturer Narrative
Investigation results: the complaint of needle retraction failure was confirmed due to the circumstantial evidence that was exhibited in the provided photograph.The photo showed a needle that was extending from the grip.The top web of an 18g insyte autoguard device from lot #2305377 was shown in the photo.The iv catheter was missing from the needle.What appeared to be blood residue was visible within the flash chamber of the needle hub.As the photograph supports the complainant¿s description of the reported retraction failure, the complaint was confirmed; however, the root cause could not be determined without the physical sample.No other similar complaints were reported from the implicated lot.The complaint that the catheter could not be advanced could not be confirmed from the photograph since the iv catheter had been removed from the needle and was not shown in the photo.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 AIG BC PRO
• 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: 21915525
• Report Number: 1710034-2025-00686
• Device Sequence Number: 11817619
• Product Code: FOZ
• UDI-Device Identifier: 00382903925445
• UDI-Public: (01)00382903925445(11)221102(17)251031(10)2305377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 10/31/2025
• Device Catalogue Number: 392544
• Device Lot Number: 2305377
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/26/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown