MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY; N/A

Model Number	386807
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd cathena safety iv catheter bd multiguard technology safety activation failure.This was discovered after use.The following information was provided by the initial reporter: the safety system did not engage when the catheter was removed.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo and one sample was received by our quality team for evaluation.Upon visual inspection of the photo, it was observed that the safety mechanism failure was not activated.Upon visual inspection of the sample, it was observed that needle through catheter had occurred.The sample was then subjected to manual safety activation testing and no abnormality was observed; therefore, the incident reported could not be verified.A device history record could not be evaluated as the lot number is unknown.Based on the investigation, a root cause could not be determined.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd cathena safety iv catheter bd multiguard technology safety activation failure.This was discovered after use.The following information was provided by the initial reporter: the safety system did not engage when the catheter was removed.

• Brand Name: BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY
• Common Device Name: N/A
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9643702
• Report Number: 8041187-2020-00024
• Device Sequence Number: 16610926
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (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): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other