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

Model Number	386806
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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 or Problem 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.
Additional 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¿
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15140905
• Report Number: 8041187-2022-00416
• Device Sequence Number: 7330335
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: 00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: Health Professional
• Device Expiration Date: 09/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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