MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
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 insyte yel 24ga x 0.75in catheter defective / damaged / deformed.On (b)(6)2024, in a pediatric intensive care unit, a peripheral catheter was inserted without difficulty in a child.24 hours later, when changing the catheter's fixation, the ide noticed a diffusion of the perfalgan administered.She removed the catheter and found it to be pierced.There were no consequences for the patient.This is a recurring incident, despite the supplier's training of the teams.
Event or Problem Description
On (b)(6) 2024, in a pediatric intensive care unit, a peripheral catheter was inserted without difficulty in a child.24 hours later, when changing the catheter's fixation, the ide noticed a diffusion of the perfalgan administered.She removed the catheter and found it to be pierced.There were no consequences for the patient.This is a recurring incident, despite the supplier's training of the teams.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From returned sample, needle pierced through catheter was observed.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Current control, there is in-process inspection in place to check for needle pierced through catheter.Needle pierced through catheter could happen during product application when the product was manipulated, or during needle cover removal, if not done carefully.As the actual sample was used, actual root cause could not be established.

• Brand Name: BD INSYTE YEL 24GA X 0.75IN
• 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: 20649337
• Report Number: 2243072-2024-01115
• Device Sequence Number: 3200770
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127(11)240120(17)281231(10)4008894
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 381212
• Device Lot Number: 4008894
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/10/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown