MAUDE Adverse Event Report: BD CATHENA¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Model Number	386804
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
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 2 bd cathena¿ safety iv catheters' safety mechanisms failed to activate during use.The following information was provided by the initial reporter: one of our nurses just started an iv on a patient and when they pulled back, the safety mechanism did not activate, totally exposing the needle and putting staff and patient at risk of needle stick injury.One other nurse commented that it has happened to her twice and she is aware that this failure of the safety mechanism has occurred for other staff recently.
Event or Problem Description
It was reported that 2 bd cathena¿ safety iv catheters' safety mechanisms failed to activate during use.The following information was provided by the initial reporter: one of our nurses just started an iv on a patient and when they pulled back, the safety mechanism did not activate, totally exposing the needle and putting staff and patient at risk of needle stick injury.One other nurse commented that it has happened to her twice and she is aware that this failure of the safety mechanism has occurred for other staff recently.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received by our quality team for evaluation.From the photos, it was observed that the safety mechanism was observed to not be fully activated and there was blood at the needle hub flashback chamber.Dhr was performed.A similar quality notification was raised in the past 12 months for this defect.The root cause was a loosened screw caused misalignment during cannula insertion to the hub process and resulted in a dent on the cannula.H3 other text : see h.10.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12260263
• Report Number: 8041187-2021-00673
• Device Sequence Number: 11977073
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2021

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: 01/31/2022
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 9042610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/29/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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