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

Catalog Number	382912
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/29/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that during use with bd insyte autoguard¿ bc pro winged shielded iv catheter the catheter bent piercing or snapping the vein.Reported that death occurred, events regarding the patients death, and how it was related to our device has not been obtained.The following information was provided by the initial reporter, translated from french to english: management of a 25-month-old child with hyperthermia and asthenia.We observe a rapid deterioration of the patient, necessitating the insertion of a venous catheter.For this, we use the equipment made available to us by the pharmacy.The bd insyte autoguard bc pro 24g catheter is difficult to handle.Once the vein has been punctured, the catheter bends at 45°, piercing or snapping the vein.If you manage to insert the catheter, you have to keep it pressed down to inject the therapies.
Additional Manufacturer Narrative
B.2 date of death: the date of death was not able to be obtained, therefore, the event date was used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
H.6.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.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that during use with bd insyte autoguard¿ bc pro winged shielded iv catheter the catheter bent piercing or snapping the vein.Reported that death occurred, events regarding the patients death, and how it was related to our device has not been obtained.The following information was provided by the initial reporter, translated from french to english: management of a 25-month-old child with hyperthermia and asthenia+++.We observe a rapid deterioration of the patient, necessitating the insertion of a venous catheter.For this, we use the equipment made available to us by the pharmacy.The bd insyte autoguard bc pro 24g catheter is difficult to handle.Once the vein has been punctured, the catheter bends at 45°, piercing or snapping the vein.If you manage to insert the catheter, you have to keep it pressed down to inject the therapies.

• Brand Name: BD INSYTE AUTOGUARD¿ BC PRO WINGED 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17398764
• Report Number: 1710034-2023-00829
• Device Sequence Number: 14935343
• Product Code: FOZ
• UDI-Device Identifier: 00382903925124
• UDI-Public: (01)00382903925124
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 382912
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown