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

Model Number	392637
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter sheared apart during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "i have received two reports of defective iv catheters- one from ems providers and one from an ed staff rn.In both instances, report of shearing of the iv catheter.No patient harm noted in either event.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 3010249; d4: medical device expiration date: 31-jan-2026; h4: device manufacture date: 14-jan-2023.D10: device available for eval yes, d10: returned to manufacturer on: 16-may-2023.H6: investigation summary bd received twenty eight 20 gauge insyte autoguard blood control winged units from lot 3010249 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no physical damage or deformities.Next, the units were tested for leakage to identify any damage that could not be identified by the naked eye but no leaks were found.No damage or defects were found to the returned units.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during inspection a definitive root cause could not be determined.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter sheared apart during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "i have received two reports of defective iv catheters- one from ems providers and one from an ed staff rn.In both instances, report of shearing of the iv catheter.No patient harm noted in either event.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO 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 ; 8448235433
• MDR Report Key: 16989871
• Report Number: 1710034-2023-00560
• Device Sequence Number: 15024244
• Product Code: FOZ
• UDI-Device Identifier: 00382903926374
• UDI-Public: 00382903926374
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/10/2023

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 392637
• Device Catalogue Number: 392637
• Device Lot Number: 3010249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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