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 No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that both the prn and tubing clamp of the bd intima ii¿ iv catheter prn adapter were loose during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the user found problems during the use of products in the ct room.The teacher put the needle in, had done the action of sealing the tube, also clamped the small clip.But the patient's blood flows out of the little clips, which are not tight; the knob on one end of the heparin cap on the y-block will also be unscrewed" high-resolution photos have been provided, and the samples have been discarded and cannot be returned.The blood does not leak and the patient does not need treatment.The patient is in a bad mood and is not harmed.The blood did not touch the operator's skin.

Event Description

It was reported that both the prn and tubing clamp of the bd intima ii¿ iv catheter prn adapter were loose during use.The following information was provided by the initial reporter, translated from chinese to english: "the user found problems during the use of products in the ct room.The teacher put the needle in, had done the action of sealing the tube, also clamped the small clip.But the patient's blood flows out of the little clips, which are not tight; the knob on one end of the heparin cap on the y-block will also be unscrewed." "1.High-resolution photos have been provided, and the samples have been discarded and cannot be returned.2.The blood does not leak and the patient does not need treatment.3.The patient is in a bad mood and is not harmed.4.The blood did not touch the operator's skin.".

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 0168658.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 IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11102930
• MDR Text Key: 227971768
• Report Number: 3006948883-2020-01077
• 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,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/22/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0168658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1