MAUDE Adverse Event Report: BD CATHENA¿ SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386804
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
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 experienced leakage.The following information was provided by the initial reporter: the patient had to be repicked.When placing the vvp, the catheter has its base during the placement.It looks defective.The blood leak was not due to leaving the stylet and allowing blood to flow out, the leak was when the catheter was withdrawn from the tubing.
Additional Manufacturer Narrative
H.6.Investigation: 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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced leakage.The following information was provided by the initial reporter: the patient had to be repicked.When placing the vvp, the catheter has its base during the placement.It looks defective.The blood leak was not due to leaving the stylet and allowing blood to flow out, the leak was when the catheter was withdrawn from the tubing.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12178532
• Report Number: 8041187-2021-00596
• Device Sequence Number: 1533445
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Expiration Date: 02/28/2022
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 9057619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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