MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	386812
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone#: 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.
Event or Problem Description
It was reported that the hub of the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology was defective and disconnected from the luer-lock of the infusion set during use, causing fluid to leak out.The following information was provided by the initial reporter, translated from spanish: "disconnection and fluid leakage at the junction of the catheter hub with the luer lock connection of the infusion set.Disconnection and fluid leakage at the junction of the catheter hub with the luer lock connection of the infusion set or extension set.During use.".
Event or Problem Description
It was reported that the hub of the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology was defective and disconnected from the luer-lock of the infusion set during use, causing fluid to leak out.The following information was provided by the initial reporter, translated from spanish: "disconnection and fluid leakage at the junction of the catheter hub with the luer lock connection of the infusion set.Disconnection and fluid leakage at the junction of the catheter hub with the luer lock connection of the infusion set or extension set.During use.".
Additional Manufacturer Narrative
H6: investigation summary: no photos displaying the reported condition or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15695691
• Report Number: 8041187-2022-00630
• Device Sequence Number: 17981813
• Product Code: FOZ
• UDI-Device Identifier: 00382903868124
• UDI-Public: (01)00382903868124
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201717
• 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): 11/28/2022

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 Model Number: 386812
• Device Catalogue Number: 386812
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/06/2022
• 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
• Patient Sex: Unknown