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

Model Number	381533
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
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 that the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub when removing the protector.This occurred with 3 catheters during use.The following information was provided by the initial reporter: "customer states that they had 3 iv cath coming off with the protector.".
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received three 20g x 1.00in.Insyte autoguard winged units.Two of the units were returned in sealed packaging with the labeling indicating that they were from lot number 0057971.The third unit was returned unused without any packaging.Based on the report, the defect of the catheter being removed with the needle cover was not confirmed.A gross visual inspection did not find any damage to the components.The needle cover and catheter assemblies were found to be oriented correctly.Misorientation of either component is known to cause the catheter to lodge in the needle cover and unseat the catheter assembly when removing the needle cover.The units were functionally tested by removing the needle cover and observing for any unseating of the catheter assembly.The needle cover removed normally, and the catheter remained seated against the needle hub.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in this report.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub when removing the protector.This occurred with 3 catheters during use.The following information was provided by the initial reporter: "customer states that they had 3 iv cath coming off with the protector.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13960943
• Report Number: 1710034-2022-00155
• Device Sequence Number: 14680241
• Product Code: FOZ
• UDI-Device Identifier: 30382903815334
• UDI-Public: 30382903815334
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/01/2022

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 Expiration Date: 01/31/2023
• Device Model Number: 381533
• Device Catalogue Number: 381533
• Device Lot Number: 0057971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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