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

Catalog Number	381523
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged plastic burr on the catheter hub connector.The following information was provided by the initial reporter: the customer has stated that there is a burr on the insyte autoguard winged 22g by 1in.Catheter on multiple units so they have pulled the lot from inventory.The burr has made it an issue tightening on their extension tubing to the iv, so this is something needing fixing.28 aug date: aug 21st, 2024 no injury reported to patient or clinician.No physical sample, just picture evidence of the burr.There wasn¿t patient impact, if the iv was started and they could not connect the extension tubing to the hub, they had to restart an iv.Due to this issue patients were having to get poked more than necessary.
Additional Manufacturer Narrative
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph of the implicated 22g winged autoguard iv catheter.The catheter adapter appeared to contain deformation in the threaded region where a flattened piece of adapter material was seen extending past the luer adapter threads, which likely affected the ability to make a proper connection.Your reported issue was confirmed as the burr was found to be the flattened piece of adapter.This was evidence to confirm a manufacturing related issue.Damage to the catheter adapter can occur during manufacturing due to the device handling within the machinery.This can occur due to misalignment of the machine grippers.The appropriate personnel have been notified.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 20190884
• Report Number: 1710034-2024-01011
• Device Sequence Number: 12540759
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/10/2024

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: 381523
• Device Lot Number: 4123605
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown