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

Model Number	386813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
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.(b)(6).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 a damaged catheter tip.The following information was provided by the initial reporter: in the context of an mri-examination the patient reported unusual heat pain at the arm exactly where the catheter was placed.After checking the cannula i noticed it has a metal coil.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced a damaged catheter tip.The following information was provided by the initial reporter: in the context of an mri-examination the patient reported unusual heat pain at the arm exactly where the catheter was placed.After checking the cannula i noticed it has a metal coil.
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, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12345523
• Report Number: 8041187-2021-00750
• Device Sequence Number: 4633537
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/15/2021

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: 386813
• Device Catalogue Number: 386813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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