MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386804
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that cathena 20gx1.25in straight bc leaked.The following information was provided by the initial reporter: anti-reflux valve repeatedly non-functional.
Additional Manufacturer Narrative
H6: investigation summary one sample with open packaging and one representative sample was received by our quality team for evaluation.The samples were subjected to the blood escape time (bet) test, flashback test, and the catheter leak test.Both samples passed all testing and no abnormalities were observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 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.
Event or Problem Description
It was reported that cathena 20gx1.25in straight bc leaked.The following information was provided by the initial reporter: anti-reflux valve repeatedly non-functional.

• Brand Name: CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11408212
• Report Number: 8041187-2021-00149
• Device Sequence Number: 14585703
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• 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 Expiration Date: 11/30/2021
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 8327771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1