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

Model Number	386810
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: 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 blood control feature on the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology failed to work during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the mechanism that ensures the non-return of blood did not work during the installation of a kit.".
Additional Manufacturer Narrative
H6: investigation summary no photos 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.
Event or Problem Description
It was reported that the blood control feature on the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology failed to work during use.The following information was provided by the initial reporter, translated from french to english: "the mechanism that ensures the non-return of blood did not work during the installation of a kt".

• 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
• MDR Report Key: 11657181
• Report Number: 8041187-2021-00275
• Device Sequence Number: 17018736
• Product Code: FOZ
• UDI-Device Identifier: 00382903868100
• UDI-Public: 00382903868100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 386810
• Device Catalogue Number: 386810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1