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	10/28/2024
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 22gx1.00in straight bc leaked at catheter junction leakage at the connection point between cannula and catheter during use after use of the device on the patient it is observed that there is leakage at the joint of the cone with the cannula.Observed during infusion.Catheter allows blood to be drawn.
Event or Problem Description
Leakage at the connection point between cannula and catheter during use after use of the device on the patient it is observed that there is leakage at the joint of the cone with the cannula.Observed during infusion.Catheter allows blood to be drawn.
Additional Manufacturer Narrative
Our quality engineer inspected the photos, and 5 samples submitted for evaluation.The reported issue of leakage at insertion site was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.The samples were subjected to a catheter leak test and all samples passed with no abnormalities observed.The root cause could not be determined as the defect was not replicated.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 20730053
• Report Number: 2243072-2024-01143
• Device Sequence Number: 8500021
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063(11)240505(17)270430(10)4124013
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 4124013
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown