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

Model Number 386806

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

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 10 bd cathena¿ safety iv catheter with bd multiguard¿ experienced leakage.The following information was provided by the initial reporter: end users potentially exposed to blood(staff pinching off catheter to minimize risk of blood exposure) as cathena is missing blood control feature.10 catheters impacted over the last few weeks.Patient is not impacted as staff, pinch off the catheter to minimize blood loss to patient.

Event Description

It was reported that 10 bd cathena¿ safety iv catheter with bd multiguard¿ experienced leakage.The following information was provided by the initial reporter: end users potentially exposed to blood(staff pinching off catheter to minimize risk of blood exposure) as cathena is missing blood control feature.10 catheters impacted over the last few weeks.Patient is not impacted as staff, pinch off the catheter to minimize blood loss to patient.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 1280151.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a photograph was returned, but it did not display the affected device.Unfortunately, a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15140905
• MDR Text Key: 304877241
• Report Number: 8041187-2022-00416
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: 00382903868063
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 386806
• Device Catalogue Number: 386806
• Device Lot Number: 1280151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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