MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN; PERIPHERAL IV CATHETERS

Catalog Number	381544
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.Device return is not anticipated.If additional information becomes available a supplemental will be filed.
Event or Problem Description
It was reported that bd insyte autoguard winged gn 18ga x 1.16in catheter hub is chipped and unable to connect.The following information was provided by the initial reporter: hub of catheter was chipped and unable to screw onto iv extension set.1.Could you please provide a further description of the issue?: hub of catheter was chipped and unable to screw onto iv extension set 2.What was the impact to the patient?: patient needed to be stuck twice for iv placement.3.Please confirm a product is still operable or not?: needed to use another angiocath.4.Did the event directly, or indirectly involve a patient or user?: yes, a patient was involved.5.Whether issue identified before or after the event?: issue was identified when the catheter would not screw into the extension set.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN
• 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) ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18044594
• Report Number: 1710034-2023-01239
• Device Sequence Number: 7468551
• Product Code: FOZ
• UDI-Device Identifier: 00382903815449
• UDI-Public: (01)00382903815449
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/12/2024

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: Other
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 381544
• Device Lot Number: 1323289
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown