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

Catalog Number 383007

Device Problem Leak/Splash (1354)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1230637.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on the description of the event, our engineers were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd intima-ii is an infusion only device and is not rated for high pressure injections.Bd encourages the review of the instructions for use included with all intima-ii units; bd will continue to track and trend for this issue.

Event Description

It was reported that the bd intima-ii¿ iv catheter experienced leakage at the connection site.The following information was provided by the initial reporter: the indwelling needle was clamped before the placement of the patient, and opened after the placement was completed.Fluid leakage and blood leakage were found at the clamp part of indwelling needle.

• Brand Name: BD INTIMA-II¿ IV CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15276862
• MDR Text Key: 305425223
• Report Number: 3014704491-2022-00371
• Device Sequence Number: 1
• Product Code: FOZ
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383007
• Device Lot Number: 1230637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1