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

Model Number	382637
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the photograph submitted for evaluation.The photo displayed the labels of two packages from material #382637, lot #0190042.Visual observation of the photo revealed there was no view of a device for investigation.Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Additional inspections or investigation into the reported defect could not be performed without the physical sample.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract.There was no report of patient or user impact.  the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the photograph submitted for evaluation.The photo displayed the labels of two packages from material #382637, lot #0190042.Visual observation of the photo revealed there was no view of a device for investigation.Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Additional inspections or investigation into the reported defect could not be performed without the physical sample.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract.There was no report of patient or user impact.  the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 12965108
• Report Number: 1710034-2021-01038
• Device Sequence Number: 11860797
• Product Code: FOZ
• UDI-Device Identifier: 30382903826378
• UDI-Public: 30382903826378
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• 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
• Report Date (Section B): 11/23/2021

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 Expiration Date: 06/30/2023
• Device Model Number: 382637
• Device Catalogue Number: 382637
• Device Lot Number: 0190042
• 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: 11/10/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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