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

Catalog Number	381212
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte yel 24ga x 0.75in needle through catheter while introducing catheter.On (b)(6) 2024, during the insertion of a peripheral venous line in a paediatric intensive care unit, the catheter was pierced by the mandrel.A second device was tested by the nurse in accordance with the supplier's recommendations, but was also pierced by the mandrel before insertion.This is a recurring incident with no consequences for the patient, despite the supplier's training of the teams.The device involved in this incident is available for expert examination.In order to recover it, please contact us by e-mail at the following address (b)(6).There will be a delay in the preparation of the parcel (minimum 3 working days), and it can be collected from the following address between 2 and 5 pm: (b)(6).I look forward to receiving your conclusions on this incident and remain at your disposal for any further information.
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
Based on device history record review, no abnormality was observed during the production of the affected batch.From returned sample 1, the ¿v-cut¿ on the catheter that matches the shape of the bevel, which could be caused by needle pierced through catheter.From returned sample 2, 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 samples were used, actual root cause could not be established.
Event or Problem Description
On (b)(6)2024, during the insertion of a peripheral venous line in a paediatric intensive care unit, the catheter was pierced by the mandrel.A second device was tested by the nurse in accordance with the supplier's recommendations, but was also pierced by the mandrel before insertion.This is a recurring incident with no consequences for the patient, despite the supplier's training of the teams.The device involved in this incident is available for expert examination.In order to recover it, please contact us by e-mail at the following address: (b)(6) there will be a delay in the preparation of the parcel (minimum 3 working days), and it can be collected from the following address between 2 and 5 pm: (b)(6).I look forward to receiving your conclusions on this incident and remain at your disposal for any further information.

• 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: 20637927
• Report Number: 2243072-2024-01108
• Device Sequence Number: 7463844
• 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: 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: 11/08/2024
• 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