MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER

Catalog Number	386807
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology disconnected from the hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the four defects are: leakage at insertion side: "it is reported that after insertion of the catheter the insertion site is very dilated, which even causes the medication to leak out almost unnoticed." phlebitis: "increased incidence of phlebitis.Since using the catheter, they have noticed and measured an increase in mechanical phlebitis that develops within a few hours after insertion of the device." defective: "after successful insertion, if blood collection is required, it is necessary to remove part of the catheter." catheter separation: "devices connected to the catheter are disconnected after a period of time.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure modes could not be verified, and the root causes could not be determined.A device history record could not be evaluated as the lot number is unknown.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology disconnected from the hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the four defects are: 1) leakage at insertion side: "it is reported that after insertion of the catheter the insertion site is very dilated, which even causes the medication to leak out almost unnoticed." 2) phlebitis: "increased incidence of phlebitis.Since using the catheter, they have noticed and measured an increase in mechanical phlebitis that develops within a few hours after insertion of the device." 3) defective: "after successful insertion, if blood collection is required, it is necessary to remove part of the catheter." 4) catheter separation: "devices connected to the catheter are disconnected after a period of time."".

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17472216
• Report Number: 8041187-2023-00403
• Device Sequence Number: 7347563
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K220584
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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
• Patient Sex: Unknown