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

Model Number	386811
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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 cathena¿ safety iv catheter with wings and bd multiguard¿ technology leaked contrast media during the high-pressure injection.The following information was provided by the initial reporter, translated from french: "during injections of contrast products (viscous and thick) at a flow rate of 4-5cc/s, the overpressure created leads to a leakage of the contrast product and the impossibility of making images at an "arterial" time.Consequences: leakage of sticky contrast medium on our fragile machines.Failed examinations with diluted contrast products on a patient with moderate renal insufficiency.Impossibility of knowing the exact quantity of product injected.Loss of time.Having to re-inject patients to place a new catheter".
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings and bd multiguard¿ technology leaked contrast media during the high-pressure injection.The following information was provided by the initial reporter, translated from french: "during injections of contrast products (viscous and thick) at a flow rate of 4-5cc/s, the overpressure created leads to a leakage of the contrast product and the impossibility of making images at an "arterial" time.Consequences: leakage of sticky contrast medium on our fragile machines.Failed examinations with diluted contrast products on a patient with moderate renal insufficiency.Impossibility of knowing the exact quantity of product injected.Loss of time.Having to re-inject patients to place a new catheter.".
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND 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 ; 8448235433
• MDR Report Key: 16763350
• Report Number: 8041187-2023-00162
• Device Sequence Number: 6182372
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220584
• 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): 04/28/2023

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 Expiration Date: 08/31/2025
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: 2238458
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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