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

Catalog Number 383019

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 1051539.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.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 will continue to track and trend for this issue.

Event Description

It was reported that intima-ii y 22gax1.00in prn/ec slm leaked.The following information was provided by the initial reporter: "when doing enhanced ct, the indwelling needle is found to be damaged and leaking, and re-puncture, it may cause physical discomfort.".

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 12351479
• MDR Text Key: 267720966
• Report Number: 3006948883-2021-00890
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 08/09/2021

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 Expiration Date: 03/29/2024
• Device Catalogue Number: 383019
• Device Lot Number: 1051539
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2021
• 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