MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381533
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a bd insyte autoguard shielded iv catheter had the cannula break off inside the patient's vein, requiring surgical intervention.Additionally, another catheter broke off in the patient's vein, also requiring surgical intervention.The following information was provided by the initial reporter: ".I have been injured by you guys twice i have had two ivs break in my arm in a span of two months which both require surgery".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported a bd insyte autoguard shielded iv catheter had the cannula break off inside the patient's vein, requiring surgical intervention.Additionally, another catheter broke off in the patient's vein, also requiring surgical intervention.The following information was provided by the initial reporter: ".I have been injured by you guys twice i have had two ivs break in my arm in a span of two months which both require surgery.".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received eight photos.One of the photos displayed a view of the catheter adapter that appeared to be missing the catheter tubing.Damage to the catheter tubing that leads to separation from the catheter adapter can occur both in the manufacturing environment and in the user environment during application.Unfortunately, the photo provided a very limited view.In order to perform a comprehensive investigation for this defect, a physical sample of the adapter and/ or catheter tubing would be required so the separation site could be inspected microscopically.Based on the photos alone, bd was unable to determine a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12849396
• Report Number: 1710034-2021-01002
• Device Sequence Number: 17164024
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: 00382903815333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 381533
• Device Lot Number: 1104336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED BD CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown