MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 24GX0.75IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386807
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena 24gx0.75in straight bc catheter defective/damaged it was reported by customer that the cathlons are bubbled at the tip, this causes an inability to go through the skin and if they manage to get through the skin, it gets caught up trying to get into the vein.This ends up often being 2 iv attempts for the patient.Rcc received a complaint via email.Ahs mdip report incident or problem information ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2025 type of incident/problem: failure (i.E.While preparing for, in use, after use) level of harm: minimal harm ahs optional report to cmdsnet (health canada): incident details: cathlons are "bubbled" at the tip, this causes an inability to go through the skin and if you manage to get through the skin it gets caught up trying to get into the vein.This ends up often being 2 iv attempts for the pt, all staff have noticed this as an issue for at least the last 4 weeks.Procedure: iv insertion device information device name/description: catheter iv safety non-winged with multiguard 24gax0.75in cathena manufacturer: xxxxxxxx manufacturer code/model: 386807 serial or lot number: unknown supplier: xxxxxxx supplier/catalogue number: 333-386807 is the device retained? yes, number of devices: 2 wiped, contained, labelled? device was clean or not used investigation request expected type of investigation: actual device tested e-mail address for person holding device: xxxxxxxxx site shipping address: xxxxxxxx, clinical contact information, primary clinical contact (cc on final report): xxxx, manager (cc on final report): xxxxxxx.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.
Additional Manufacturer Narrative
Our quality engineer inspected the 3 samples submitted for evaluation.The reported issues of catheter defective/ damaged and threading difficult were not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.No bubbles were noted on the catheter tip.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.The root cause could not be determined as the defect was not replicated.

• Brand Name: BD CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22186981
• Report Number: 2243072-2025-00738
• Device Sequence Number: 20958677
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: (01)00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

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 Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/05/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/09/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown