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 Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
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-w winged bl 22ga x 1.0in catheter defective / damaged after the patient was admitted to the operating theatre for intravenous infusion, a 0.1mm tear was found at the hose of the 22-gauge intravenous needle after successful placement of the needle, and there was fluid exudation.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
1.Based on the complaint information, we have checked the production information, "4084140" was not found in production infromation 2.No defective sample was returned and customer returned one photo, which leakage occurs at the middle of extension tubing.3.Based on the complaint information, we have checked the production information, "4084140" was not found in production infromation, retain sample analysis was not performed 4.When the extension tubing is pinched to one side and not centered in the pinch clamp, the extension tubing may be damaged.Conclusion(s): according to the complaint information, after checking the production information, the complaint batch "4084140" has not been found, and the defective sample has not been received, so further analysis cannot be carried out, so the root cause of the complaint defect cannot be confirmed.

• 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: 20800169
• Report Number: 2243072-2024-01181
• Device Sequence Number: 15161725
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: (01)00382903813230(11)240403(17)290331(10)4084140
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown