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	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n yel 24ga x 0.56in catheter defective/ damaged it was reported that the baby is cannulated, the catheter packaging is opened, the catheter is loosened from the core and when this procedure is performed the core goes to one side (it twists when the catheter is removed) the catheter is loosened in a very delicate way.Lot number: 4058321.The catheter is kept; it is in the office.Additional information received on 07/30/2025 is there any patient impact, if yes, please explain in detail? a: there was no impact on the patient.Could you please share the photo samples related to this event? a: evidence is sent can you please confirm the affected quantity? a: 1 unit for sample collection: please inform: the sample has already been shipped.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issues of catheter defective/ damaged was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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.

• 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 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: 22794089
• Report Number: 2243072-2025-00992
• Device Sequence Number: 8264868
• Product Code: FOZ
• UDI-Device Identifier: 00382903812110
• UDI-Public: (01)00382903812110(11)240303(17)290228(10)4058321
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 381211
• Device Lot Number: 4058321
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown