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

Model Number	381444
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.E.4.The initial reporter also notified the fda on 24-mar-2023.Medwatch report #mw5115859.
Event or Problem Description
It was reported that the bd insyte autoguard straight was noticed to be broken causing leakage.The following information was provided by the initial reporter: iv fluids was hooked up to cathlon, it was leaking.Fluids were changed hoping it was from the iv tubing.Iv was still leaking.Fluids removed and hook up to j-loop(iid) and flush, still leaking.Once we were able to examine the green cathlon, we noticed that part of the hub was broken and it was never going to seal.
Additional Manufacturer Narrative
There was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.H3 other text : see h10.
Event or Problem Description
It was reported that the bd insyte autoguard straight was noticed to be broken causing leakage.The following information was provided by the initial reporter: iv fluids was hooked up to cathlon, it was leaking.Fluids were changed hoping it was from the iv tubing.Iv was still leaking.Fluids removed and hook up to j-loop(iid) and flush, still leaking.Once we were able to examine the green cathlon, we noticed that part of the hub was broken and it was never going to seal.

• Brand Name: BD INSYTE AUTOGUARD STRAIGHT
• 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 ; 8448235433
• MDR Report Key: 16727286
• Report Number: 1710034-2023-00410
• Device Sequence Number: 8079746
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: (01)30382903814443
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• 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): 05/15/2023

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: 381444
• Device Catalogue Number: 381444
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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