MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383069

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii y 22gax1.00in prn ec slm npvc leaked the following information was provided by the initial reporter: patient 2024.3.20 at about 15:00 in our department for abdominal ct enhancement examination, the nurse in the right elbow vein for the indwelling needle, high-pressure syringe pushed the contrast agent in the process of pressure changes, immediately stop the examination, found that the indwelling needle part of the parts of the detachment of the needle, the contrast agent from the indwelling needle breakage of the spillage.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19209794
• MDR Text Key: 341678250
• Report Number: 3002601200-2024-00159
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830695
• UDI-Public: (01)00382903830695
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 383069
• Device Lot Number: 3325896
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1