MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/26/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd intima-ii¿ closed iv catheter systems had white, powdery foreign matter in them during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "at 11:15 noon on (b)(6) 2021, the nurse performed indwelling needle catheterization for the newborn patient according to the doctor's advice.During the catheterization process, the indwelling needle was found to be very blunt and difficult to insert.After the catheterization failed, the indwelling needle was removed and white powdery substance was found in the hose.The nurse confirmed that the powder substance was not found before the insertion of the catheter, but appeared after the withdrawal of the indwelling needle.The nature of the powder was not sure, and it could be erased by light swab.The same adverse events occurred twice in a row in this lot.The failure of indwelling needle catheterization increased the number of catheterization and increased the pain of patient.".

Manufacturer Narrative

Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 1020969.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• MDR Report Key: 12542695
• MDR Text Key: 282292015
• Report Number: 3014704491-2021-00168
• 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: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Catalogue Number: 383028
• Device Lot Number: 1020969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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