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

Catalog Number	381311
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n winged yel 24ga x 0.56in needle through catheter.Needle through in cathether.
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.Needle through catheter.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.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.Needle pierced through catheter could happen during product application when the product was manipulated, or during needle cover removal.Tip spear.From the returned sample #2, tip spear was observed on the catheter tip.The assembly process was reviewed.If the catheter tip was torn during the manufacturing process, the defect would be detected and auto rejected by the inline tip spear 100% vision inspection system due to not meeting the tip quality requirement.While challenged with the complaint sample, the vision system was able to reject the sample.Needle pierced through catheter could happen during needle cover removal, if not done carefully.As current controls, there are daily outgoing inspection and hourly in-process inspection in place to check for catheter tip damage and needle pierced through catheter.Unable to establish the actual root cause as the samples were returned with open packaging.
Event or Problem Description
Needle through in catheter - based on the picture available in the attachments.

• Brand Name: BD INSYTE-N WINGED 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: 19519230
• Report Number: 2243072-2024-00694
• Device Sequence Number: 18205726
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: (01)00382903813117
• 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: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 381311
• Device Lot Number: 3203273
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown