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

Catalog Number 383019

Device Problem Leak/Splash (1354)

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 22gax1.00in prn/ec slm leaked.On (b)(6) 2024, a patient needed to inject a contrast agent to assist in the examination, the imaging nurse injected the needle back to normal, the test injection of saline 10 ml without any abnormality, the injection of contrast agent needle connected to the hose on the 2mm burst leakage of the drug.After the leakage, the nurse stopped the injection immediately, calmed the patient and replaced the indwelling needle to re-inject the contrast agent to complete the examination.This resulted in a small amount of contrast agent being wasted, leading to secondary puncture injury to the patient.

Manufacturer Narrative

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

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review(lot#2252622): 1)this batch of products were assembled at intima ii auto line 3 in october 2022, and packaged at r240 package line in october 2022.Work order quantity was (b)(4) ea.2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3)review the production records with no nonconformance, deviation or rework activities.2.No actual samples and photos returned.3.Functional test (45psi leakage test) is conducted on the retained sample of the complained batch, and no leakage is found.Please refer to the attached test report.4.Sku#383019 is an intima ii product (pvc extension tubing, y pp connector), which has not been declared to be used for high-pressure injection.The intended use for the bd intima ii product is the intravascular administration of fluids.Conclusion(s): no abnormality is found on process and retained sample.Since the product is not suitable for high pressure injection contrast media, the root cause of the complained defect is related to the wrong use of the product.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• 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); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19176860
• MDR Text Key: 341701601
• Report Number: 3002601200-2024-00150
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 05/10/2024

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: Other
• Device Catalogue Number: 383019
• Device Lot Number: 2252622
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1