MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381323
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-w winged bl 22ga x 1.0in needle through catheter use of the emergency trolley need to insert a line => blue catheter = the canula pierces the plastic catheter when i move it to check that the dm is working properly.Valid for the 2 catheters on the emergency trolley.
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
A box was received by our quality team for evaluation.However, no insyte samples were in the box, so an investigation could not be completed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the sample.Analysis of the sample showed the needles had pierced through the catheter tip.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 had pierced through 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 control is an in-process inspection in place to check for needles that have pierced through the catheter.As the samples were returned in open packaging, the actual root cause could not be established.

• Brand Name: BD INSYTE-W WINGED BL 22GA X 1.0IN
• 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: 21720638
• Report Number: 2243072-2025-00391
• Device Sequence Number: 14384826
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: (01)00382903813230(11)211025(17)261031(10)1298076
• 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,Followup
• Report Date (Section B): 05/19/2025

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: 381323
• Device Lot Number: 1298076
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 05/19/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown