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

Model Number	392523
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
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¿ bc pro shielded iv catheter was cracked.The following information was provided by the initial reporter: verbatim: "the reported problem was the plastic catheter left in the patient arm was cracked and started leaking as soon as the needle was retracted.We have pulled this entire lot out of inventory.Please help with next steps".
Additional Manufacturer Narrative
B5.Describe event or problem: it was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter was cracked and leaked.The following information was provided by the initial reporter: verbatim: "the reported problem was the plastic catheter left in the patient arm was cracked and started leaking as soon as the needle was retracted.We have pulled this entire lot out of inventory.Please help with next steps." h.6 imdrf annex a - medical device problem code: added a code - a0504.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter was cracked and leaked.The following information was provided by the initial reporter: verbatim: "the reported problem was the plastic catheter left in the patient arm was cracked and started leaking as soon as the needle was retracted.We have pulled this entire lot out of inventory.Please help with next steps.".
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter was not retracting after placement.The following information was provided by the initial reporter: verbatim: "needle not retracting when iv catheter placement was completed.".
Additional Manufacturer Narrative
H6: investigation summary 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.A review of the device history record was performed and no quality issues were found during production.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17080107
• Report Number: 1710034-2023-00632
• Device Sequence Number: 2249980
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: (01)00382903925230
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2023

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: 10/31/2025
• Device Model Number: 392523
• Device Catalogue Number: 392523
• Device Lot Number: 2308068
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 07/07/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/14/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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