MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386811
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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 20gx1.25in straight bc catheter tip integrity the upper plastic part of the catheter is partially severed.Several professionals have reported the incidence (so far three 20g catheters from the same lot and one 18g catheter of which we do not know the lot.The affected catheters are in the emergency room (nurse: (b)(6).
Additional Manufacturer Narrative
Our quality engineer inspected the photo, and 6 samples submitted for evaluation.The reported issue of catheter tip integrity was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.Samples were subjected to a cannula and catheter tip penetration and drag test where all samples passed with no abnormalities observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect could not be replicated.
Event or Problem Description
No additional information.

• Brand Name: BD CATHENA 20GX1.25IN 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: 21103689
• Report Number: 2243072-2024-01302
• Device Sequence Number: 8636900
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117(11)240702(17)270630(10)4180593
• 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): 02/25/2025

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: 386811
• Device Lot Number: 4180593
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown