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

Catalog Number 383033

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/01/2020

Event Type  Injury  

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 the patient developed a systemic reaction when the bd intima-ii¿ closed iv catheter system was used on them.Symptomatic treatment was used on the patient as a result, whose symptoms were relieved after 1 hour.The following information was provided by the initial reporter, translated from (b)(6) to english: "the nurse gave the patient intravenous infusion with intravenous indwelling needle at 9:30 on (b)(6) 2020.After about half an hour, the patient developed symptoms such as dizziness, nausea, vomiting, chills and fever.The nurse stopped the medicine immediately, replaced the intravenous indwelling needle, and gave symptomatic treatment.After 1 hour, the symptoms of the patient were relieved and the temperature returned to normal".

Event Description

It was reported that the patient developed a systemic reaction when the bd intima-ii¿ closed iv catheter system was used on them.Symptomatic treatment was used on the patient as a result, whose symptoms were relieved after 1 hour.The following information was provided by the initial reporter, translated from chinese to english: "the nurse gave the patient intravenous infusion with intravenous indwelling needle at 9:30 on (b)(6) 2020.After about half an hour, the patient developed symptoms such as dizziness, nausea, vomiting, chills and fever.The nurse stopped the medicine immediately, replaced the intravenous indwelling needle, and gave symptomatic treatment.After 1 hour, the symptoms of the patient were relieved and the temperature returned to normal".

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 8233366.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.Unfortunately, a sample could not be obtained for evaluation and testing.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): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10617128
• MDR Text Key: 209536979
• Report Number: 3006948883-2020-00460
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8233366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention