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

Catalog Number 383069

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

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

Event Date 11/20/2021

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.

Event Description

It was reported that 25 bd intima-ii¿ closed iv catheter systems experienced discolored catheters, and discolored end caps.The following information was provided by the initial reporter: the prn and extension tube were yellowish.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-11-22.H6: investigation summary: a device history review was conducted for lot number 0267263.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.Additionally, samples were provided to our facility to aid in evaluation and testing.Our engineers that the returned sample box had an odor consistent with disinfectant.All returned samples exhibited discoloration and corrosion.Based on our engineers analysis of the devices these observations are signs of contact with a corrosive agent or inadequate storage conditions according to the instructions for use included with this product the device must be stored in a well ventilated facility and not in the proximity of any corrosive elements.H3 other text : see h10.

Event Description

It was reported that 25 bd intima-ii¿ closed iv catheter systems experienced discolored catheters, and discolored end caps.The following information was provided by the initial reporter: the prn and extension tube were yellowish.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13040065
• MDR Text Key: 288125174
• Report Number: 3014704491-2021-00361
• 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,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/16/2023
• Device Catalogue Number: 383069
• Device Lot Number: 0267263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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