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

Catalog Number	381934
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged hub does not have threads.The following information was provided by the initial reporter: date of incident (b)(6) 2024 type of incident/problem: malfunction - during or after use level of harm- minimal harm there is no threading on the pink catheter piece the pt bled everywhere due to the heplock not being to twist on.Who was affected? patient unexpected or prolonged care? yes.Frequency of problem: recurring.30 dec: what was the impact to the patient? bleeding and having to restart iv as no threading describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Bleeding and having to restart iv.
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.
Additional Manufacturer Narrative
Investigation results: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 381934 and lot number 4155277.A quality notification related to the reported defect was initiated during the build of this lot, however without a sample we cannot confirm that this failure was related to that notification.Based on the available information, an exact cause for this incident could not be identified.
Event or Problem Description
No additional infromation.

• 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: 21067055
• Report Number: 1710034-2024-01565
• Device Sequence Number: 8398649
• Product Code: FOZ
• UDI-Device Identifier: 00382903819348
• UDI-Public: (01)00382903819348(11)240604(17)270531(10)4155277
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 381934
• Device Lot Number: 4155277
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown