MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.25 IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 two bd cathena safety iv catheter bd multiguard technology 20 ga 1.25 in kinked when used.The following information was provided by the initial reporter, translated from (b)(6): "the walls of the catheter seem to stick together according to one reporter.".
Event or Problem Description
It was reported two bd cathena safety iv catheter bd multiguard technology 20 ga 1.25 in kinked when used.The following information was provided by the initial reporter, translated from french: "the walls of the catheter seem to stick together according to one reporter.".
Additional Manufacturer Narrative
Investigation summary: two representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection to check for hooked / damaged cannula point and catheter tip defect.No hooked / damaged cannula points and catheter tip defects were observed for both samples.The samples were further subjected to cannula and catheter tip penetration and drag test, both samples met the product specification.A device history record review found no non-conformances associated with this issue during production of this batch.As the returned representative samples passed the visual inspection on the catheter tip defect and cannula hooked / damaged point.After the catheter was manually removed from the needle, the catheter wall did not collapse.Both samples also passed the catheter and cannula tip penetration and drag test and flashback test (for occlusion).As no actual samples were received, the root cause cannot be determined.H3 other text : see h10.

• Brand Name: BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.25 IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12346391
• Report Number: 8041187-2021-00757
• Device Sequence Number: 4633392
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 0059299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• 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