MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381544
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that insyte autoguard winged gn 18ga x 1.16in needle broke off in the catheter.This was discovered during use.The following information was provided by the initial reporter: material no.: 381544, batch no.: 9198681.It was reported that the needle broke off in the plastic catheter while the rn was attempting to insert it into the patient.When she went to pull the needle out by retracting it, there was no needle attached at the hub.It was noticed remaining in the catheter and everything was removed immediately.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used retracted unit and the catheter adapter assembly with the original packaging.Upon inspection of the unit, the needle did not back out of the hub.However, the catheter backed out of the wedge while inspecting the device which indicated a catheter back out occurred.The failure mode could potentially be caused by incorrect swedge depth or incorrect flare length.Measurement of the swedge depth could not be performed since the wedge-tubing assembly was separated from the adapter.The adapter was evaluated and there were no molding defects found that could affect the swaging process.There were no visible marks confirming that the swaging process was not completed properly.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.Bd is continuing to further investigate this type of reported issue through capa#1461582.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that insyte autoguard winged gn 18ga x 1.16in needle broke off in the catheter.This was discovered during use.The following information was provided by the initial reporter: material no.: 381544 batch no.: 9198681.It was reported that the needle broke off in the plastic catheter while the rn was attempting to insert it into the patient.When she went to pull the needle out by retracting it, there was no needle attached at the hub.It was noticed remaining in the catheter and everything was removed immediately.

• Brand Name: INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9900764
• Report Number: 1710034-2020-00220
• Device Sequence Number: 701661
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 381544
• Device Catalogue Number: 381544
• Device Lot Number: 9198681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other