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	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 22gx1.00in straight bc blood leaks out of control plug whilst in mri department giving education on iagbc pro staff mrt mentioned that she had noted that cathena 22g was bleeding back into the hub, not giving blood control protection.This happened on the 17th february, but she had also noticed this the week prior.She mentioned that another colleague had noticed this previously also.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
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, corrective actions have been initiated, and a manufacturing root cause has been identified for this failure mode.Current control there is a functional test on blood escape time (bet) to detect septum leakage and in-process inspection to check on the septum slit quality.The vision system is challenged at each shift per daily process.

• 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: 21527703
• Report Number: 2243072-2025-00213
• Device Sequence Number: 15857817
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063(11)240831(17)270831(10)4237741
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 4237741
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown