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

Model Number 386865

Device Problems Leak/Splash (1354); Retraction Problem (1536)

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

Event Date 11/09/2021

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 the blood control safety feature on the bd cathena¿ safety iv catheter with bd multiguard¿ technology failed to allow the needle to disengage after it was inserted into the patient's vein.The following information was provided by the initial reporter: "wanted to let you know of an issue we're having with the 18 gauge cathena iv's.The needle will not disengage when the plastic catheter is inserted in the vein.It was stuck yesterday while in the the patient's vein.When we able to get the needle out, the metal was bent.Today an 18 gauge iv was stuck again when trying to insert the plastic catheter and disengage the metal needle." "there were 3 needles used on patients and discovered to be damaged that i am aware of.".

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 the blood control safety feature on the bd cathena¿ safety iv catheter with bd multiguard¿ technology failed to allow the needle to disengage after it was inserted into the patient's vein.The following information was provided by the initial reporter: "wanted to let you know of an issue we're having with the 18 gauge cathena iv's.The needle will not disengage when the plastic catheter is inserted in the vein.It was stuck yesterday while in the the patient's vein.When we able to get the needle out, the metal was bent.Today an 18 gauge iv was stuck again when trying to insert the plastic catheter and disengage the metal needle." "there were 3 needles used on patients and discovered to be damaged that i am aware of.".

Event Description

It was reported that the blood control safety feature on the bd cathena¿ safety iv catheter with bd multiguard¿ technology failed to allow the needle to disengage after it was inserted into the patient's vein.The following information was provided by the initial reporter: "wanted to let you know of an issue we're having with the 18 gauge cathena iv's.The needle will not disengage when the plastic catheter is inserted in the vein.It was stuck yesterday while in the patient's vein.When we able to get the needle out, the metal was bent.Today an 18 gauge iv was stuck again when trying to insert the plastic catheter and disengage the metal needle." "there were 3 needles used on patients and discovered to be damaged that i am aware of.".

Manufacturer Narrative

H6: investigation summary : three photos and one box of samples, one actual and fourteen representative samples, with open packaging were received by our quality team for evaluation.From the photos, the needle was observed to be bent at the mid-section of the cannula.The actual sample was observed with a dent on the mid-section of the cannula, around 1 cm from the top of the needle hub.The fourteen representative samples were also observed with a dent on the mid-section of the cannula, around 1 cm from the top of the needle hub.Different degrees of cannula dent were observed on the representative samples, with 7 units with a major dent that resulted in safety activation failure and 7 units with a slight dent that did not result in safety activation failure.The root cause was found to be a loose screw which caused misalignment during the cannula insertion to the hub process and resulted in a dent on the cannula.Checking of loose, wear & tear screw has been added to the preventative maintenance task list, and safety activation inspection was added into the in-process inspection form.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12968243
• MDR Text Key: 285558924
• Report Number: 8041187-2021-01036
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: 00382903868650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201717
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 386865
• Device Catalogue Number: 386865
• Device Lot Number: 1144979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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