MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386803
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
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 20gx1.00in straight bc blood leak out of control plug.It was reported by customer that the blood was leaking from iv catheter once inserted, prior to connection to tubing.Verbatim: rcc received a complaint via email.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: no apparent harm - reached the patient/person -- inconvenient ahs optional report to cmdsnet (health canada): incident details: iv catheters are supposed to have stopper that does not allow blood flow once iv cathether inserted, prior to connection to tubing.Multiple incidents of stopper not working in this particular lot.Nursing used to not have to compress vein post insertion but now having to revert to practice.Every episode is from this lot number.Who was affected? patient device information device name/description: catheter iv safety non-winged with multiguard 20gax1.00in cathena, manufacturer: becton dickinson canada inc, manufacturer code/model: 386803 serial or lot number: (b)(6), supplier: xxx supplier/catalogue number: 333-386803 is the device retained? yes.
Additional Manufacturer Narrative
Our quality engineer inspected the samples submitted for evaluation.The reported issue of blood leaks out of control plug was confirmed upon inspection of the samples.Due to a manufacturing defect, there is potential for a hole in the septum of the cathena 18- and 20-gauge catheters.The hole may result in blood leakage from the septum during insertion.The blood leakage may cause blood exposure or the need for a second iv to be placed.The replacement of the iv may result in a brief delay in therapy which would not be expected to result in an adverse event.Bd has identified root cause and initiated corrective actions to prevent recurrence of this issue.

• Brand Name: BD CATHENA 20GX1.00IN 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: 21900945
• Report Number: 2243072-2025-00563
• Device Sequence Number: 4059394
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032(11)240903(17)270831(10)4247809
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 386803
• Device Lot Number: 4247809
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown