MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 24GX0.75IN STRAIGHT BC; Catheter, intravascular, therapeutic, short-term less than 30 days

Catalog Number	386860
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 24gx0.75in straight bc safety mechanism will not activate.It was reported by customer that the safety did not click, stating the ¿safety cover was not there¿, and that the iv catheter is supposed to click automatically to engage the safety.The safety mechanism is a passive system, meaning that when the nurse pulls back on the frosted part after inserting the iv into a patient, the needle retracts back into that frosted part.When fully out, the whole part disengages from the spring in the hub, creating a locked safety ¿covering¿ for the sharp end of the needle.Verbatim: rcc received a complaint via email.That upon removing the iv catheter, the safety did not click, stating the ¿safety cover was not there¿, and that the iv catheter is supposed to click automatically to engage the safety.The safety mechanism is a passive system, meaning that when the nurse pulls back on the frosted part after inserting the iv into a patient, the needle retracts back into that frosted part.When fully out, the whole part disengages from the spring in the hub, creating a locked safety ¿covering¿ for the sharp end of the needle.Manufacturer response for peripheral iv, bd cathena 24ga 0.75" (per site reporter).
Additional Manufacturer Narrative
As no physical sample, lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD US CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: Catheter, intravascular, therapeutic, short-term less than 30 days
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19548240
• Report Number: 2243072-2024-00720
• Device Sequence Number: 14665482
• Product Code: FOZ
• UDI-Device Identifier: 00382903868605
• UDI-Public: (01)00382903868605
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

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: Other
• Device Catalogue Number: 386860
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown