MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-N YEL 24GA X 0.56IN; INTRAVASCULAR CATHETER

Catalog Number	381211
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
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 insyte-n yel 24ga x 0.56in catheter tip damaged / deformed / defective two medical officers have reported difficulties with use - cap difficult to remove and can no longer be done with one hand, once cap is off, the cannula tip / threading tip is moving.
Event or Problem Description
Two medical officers have reported difficulties with use - cap difficult to remove and can no longer be done with one hand, once cap is off, the cannula tip / threading tip is moving.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issues of cap tight and catheter tip integrity were not confirmed upon inspection of the sample.Analysis of the sample showed that the needle cover could be properly removed without the catheter adapter coming off with the needle cover.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.The root cause could not be determined as the defect was not replicated.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD INSYTE-N YEL 24GA X 0.56IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21253750
• Report Number: 2243072-2025-00026
• Device Sequence Number: 18406895
• Product Code: FOZ
• UDI-Device Identifier: 00382903812110
• UDI-Public: (01)00382903812110(11)230908(17)280831(10)3251844
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• 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): 02/06/2025

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: 381211
• Device Lot Number: 3251844
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown