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

Catalog Number	381034
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional lot numbers were provided in this complaint for material number 381034.Lot # 4239978 mnf date 2024-08-28 exp date 2027-07-31.Lot # 4199766 mnf date 2024-07-25 exp date 2027-06-30.Lot # 3362802 mnf date 2024-01-02 exp date 2026-12-31.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 needle did not retract.The following information was provided by the initial reporter: nurse stating cannula was not retracting when button pressed, tried multiple cannula's with the.Lot: 4239978 for same issues.Tried new lot: 4199766 same issues would not retract.Tried lot: 3362802.Would not retract as well.Tried lot 4030760, would also not retract right away.It appears as if button is getting stuck.Multiple staff tried was not user error.All cannula's removed from floor and sent to materials management.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle would not retract could not be confirmed from the 4 representative 20g insyte autoguard units that were received in sealed unit packages from lot 4239978.No samples physical samples were received for batches 4199766, 3362802, and 4030760.A functional test showed that each needle retracted within specification.No damage or defects were identified on the returned samples.Although the representative samples do not support the complainant¿s description, 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 INSYTE AUTOG BC
• 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: 21403343
• Report Number: 1710034-2025-00239
• Device Sequence Number: 15832390
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345(11)240201(17)270131(10)4030760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 381034
• Device Lot Number: 4030760
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown