MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 22GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386806
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cathena 22gx1.00in straight bc had leakage out of the control plug.The following information was provided by the initial reporter: material#: 386806 and batch#: 4205838.Verbatim: rcc received a complaint via email.New report of dissatisfaction from one of our care teams, in connection with the product 386806, batch 4205838.Similar complaint from another department on (b)(6).-comments on the current complaint received: summary description of the problem encountered: several defective catheters, control of the non-functional venous return so blood flows everywhere and needle protection system, the retraction system does not work.Problem frequency: frequently.Impact of the problem: dangerous to prick with needles and to contaminate yourself with blood.-answers to the questions you usually ask: please describe the issue that is the subject of your report in more detail.The problem is the same as what is described in the report.(venous return control problem and catheter needle does not retract.2.What was the impact of the incident on the patient? impact on nursing.3.Did the problem occur while using the product in a patient? yes, we install a venous line! was there any prejudice on the part of the latter? the impact is for the nurse a very high risk of contaminating herself with blood products and increases in exposure to blood products.If yes, please describe any medical treatment that may have been required.Does not apply, it is not a medical treatment but a care technique.4.Can you provide us with a sample or photo of the product for inquiry? we did not keep the catheter needle and for the control of the venous return it is at the moment when the catheter is installed that it happens, i cannot give you any material proof.The patient has the catheter in his arm.You can trust the nurses that we have been using these catheters for many years so they know when there is a problem with the product.No samples available.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD CATHENA 22GX1.00IN 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: 22023773
• Report Number: 2243072-2025-00650
• Device Sequence Number: 13109013
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063(11)240815(17)270731(10)4205838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220584
• 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
• Report Date (Section B): 05/23/2025

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: 386806
• Device Lot Number: 4205838
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown