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

Catalog Number	381211
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n yel 24ga x 0.56in catheter tip was cracked at the time of performing the tests with the peripheral catheter, it is evident that two peripheral catheters number 24 with a cracked tip are evident.
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 photos, and 2 samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the samples.Analysis of the samples showed a v cut near the catheter tip of the first sample and the needle pierced through the catheter on the second sample.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 assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needles can pierce through the catheter during product application, when the product was manipulated, or during needle cover removal, if not done carefully.Current controls include an in-process inspection in place to check for needles that have pierced through the catheter.Unable to establish the actual root cause as the sample was returned with open packaging.
Event or Problem Description
Additional info received _ feb 03.2025.Could you please reconfirm the material and lot number? the material provided in the report and the image are different.Please confirm the number of the material concerned.Lot: 4058321.Could you please confirm if the quantity affected is 2? yes.Was there any impact on the health of the patients? detail.Yes but without patient's data.For specimen collection: report the following: how many units are available for collection? two.Is the sample contaminated? if yes, indicate the substance.No.

• 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: 21344957
• Report Number: 2243072-2025-00065
• Device Sequence Number: 8959643
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/21/2025
• 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