MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383019

Device Problem Leak/Splash (1354)

Patient Problem Inflammation (1932)

Event Date 02/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1.Address information was not provided, therefore, xx was used as a place holder.

Event Description

It was reported bd intima ii¿ iv catheter was leaking at adapter tubing junction.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2023, a patient was given an iv infusion and left in place using a closed iv indwelling needle as prescribed by the physician.During the procedure, there was a leakage of blood from the front end of the indwelling needle at the y-type indwelling needle interface.The needle was immediately withdrawn, and the iv indwelling needle was replaced after a successful puncture.".

Manufacturer Narrative

1.Dhr/bhr review (lot#2172230): 1) this batch of products were assembled at intima ii auto line 4 in june 2022, and packaged at cfs package line in june 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 defective samples and photos have been received for the complaint.3.45psi leakage test is carried out on the retained sample of this batch, and no leakage is found.Please refer to attachment for the test report.Conclusion(s): no abnormality is found on process and retained sample.As the defective sample has not been received, further analysis cannot be done, and the root cause of the leakage of blood between the front end and the y-type interface of the indwelling needle cannot be determined.The plant will continue to track this complaint.

Event Description

No additional information provided.

• Brand Name: BD INTIMA II¿ IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• 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: 18448752
• MDR Text Key: 332159351
• Report Number: 3014704491-2023-00881
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830190
• UDI-Public: (01)00382903830190
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 02/29/2024

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: 2172230
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1