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

Model Number	392533
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).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 that 3 insyte autogard bd pro catheters had a needle that would not retract.The following information was provided by the initial reporter: 2 different nurses inserted the iv the white button that retracts the needle did not work.The white button was already pushed out.Unable to thread the catheter off the needle.The needle never retracted at all after several attempts.The incident occured 3 different times.
Event or Problem Description
It was reported that 3 insyte autogard bd pro catheters had a needle that would not retract.The following information was provided by the initial reporter: 2 different nurses inserted the iv the white button that retracts the needle did not work.The white button was already pushed out.Unable to thread the catheter off the needle.The needle never retracted at all after several attempts.The incident occured 3 different times.
Additional Manufacturer Narrative
H6: investigation summary bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

• Brand Name: INSYTE AUTOGARD BD PRO 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15912103
• Report Number: 1710034-2022-00740
• Device Sequence Number: 12102745
• Product Code: FOZ
• UDI-Device Identifier: 50382903925334
• UDI-Public: 00382903925339
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/04/2023

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: 392533
• Device Catalogue Number: 392533
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/03/2022
• Supplement Report FDA Received Date: 01/19/2023
• 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