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

Catalog Number 386862

Device Problem Leak/Splash (1354)

Patient Problems Awareness during Anaesthesia (1707); Anxiety (2328)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology leaked during use and the patient did not receive the full dose of anesthesia, causing intraprocedural awareness.The following information was provided by the initial reporter: "patient did not receive intended dose of anesthesia secondary to leakage of piv.This resulted in unintended intraprocedural awareness.No testing performed.Patient emerged from anesthesia anxious and was able to recall specific details during the procedure.Iv assessed and noted to be leaking - towel underneath iv noted to be wet/soaked.".

Event Description

It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology leaked during use and the patient did not receive the full dose of anesthesia, causing intraprocedural awareness.The following information was provided by the initial reporter: "patient did not receive intended dose of anesthesia secondary to leakage of piv.This resulted in unintended intraprocedural awareness.No testing performed.Patient emerged from anesthesia anxious and was able to recall specific details during the procedure.Iv assessed and noted to be leaking - towel underneath iv noted to be wet/soaked.".

Manufacturer Narrative

H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
• Type of Device: 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: 17839671
• MDR Text Key: 324532485
• Report Number: 8041187-2023-00515
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868629
• UDI-Public: 00382903868629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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
• Device Operator: Other
• Device Catalogue Number: 386862
• Device Lot Number: 2215676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other