MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number	386807
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd cathena safety iv catheter bd multiguard technology 24 ga 0.75 in leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about leakage with the cathena.According to the customer's report, the leakage was found from the connection between the extension tubing and the cathena hub, when the administration was performed with a cathena attached to an extension tubing three times daily in the morning, afternoon, and evening.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 20-mar-2023.H.6.Investigation summary: our quality engineer inspected the 3 sample photos and 1 sample submitted for evaluation.The reported issue of leakage at catheter junction was not confirmed upon inspection of the sample photos and sample.Analysis of the sample photos showed that there were no damages which could cause leakage on the luer connection area.Visual analysis of the returned sample confirmed the findings from the sample photo evaluations.The sample was also subjected to leakage testing and no leakage was observed during testing.Bd was unable to determine the cause of the reported failure since the failure mode reported was not confirmed during the sample evaluation.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Since no batch number was reported we were unable to review manufacturing records for this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported while using bd cathena safety iv catheter bd multiguard technology 24 ga 0.75 in leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about leakage with the cathena.According to the customer's report, the leakage was found from the connection between the extension tubing and the cathena hub, when the administraion was performed with a cathena attached to an extension tubing three times daily in the morning, afternoon, and evening.

• Brand Name: BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 24 GA 0.75 IN
• 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 ; 8448235433
• MDR Report Key: 16613025
• Report Number: 8041187-2023-00119
• Device Sequence Number: 6255092
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: (01)00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172506
• 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): 04/11/2023

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: Other
• Device Model Number: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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