MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BC PRO WINGED; INTRAVASCULAR CATHETER

Model Number	392623
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the insyte autoguard bc pro winged it was noticed blood coming out the side of the hub.The following information was provided by the initial reporter: placed a 22g insyte autoguard bc and noticed blood coming out the side of the hub.She did not save the packaging of the device but did save the catheter and hub.
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported while using the insyte autoguard bc pro winged it was noticed blood coming out the side of the hub.The following information was provided by the initial reporter: placed a 22g insyte autoguard bc and noticed blood coming out the side of the hub.She did not save the packaging of the device but did save the catheter and hub.
Additional Manufacturer Narrative
H6: investigation summary bd was unable to perform a thorough investigation as no sample or lot number were provided.A device history review could not be completed as no batch number was provided.

• Brand Name: INSYTE AUTOGUARD BC PRO WINGED
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15198496
• Report Number: 1710034-2022-00427
• Device Sequence Number: 2111590
• Product Code: FOZ
• UDI-Device Identifier: 00382903926237
• UDI-Public: 00382903926237
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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 Model Number: 392623
• Device Catalogue Number: 392623
• Device Lot Number: UNKNOWN
• 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: 07/15/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/28/2022
• 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
• Patient Sex: Unknown