MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383033

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

Patient Problem Skin Inflammation (2443)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that intima-ii y 24gax0.75in prn/ec slm caused an allergic reaction which resulted in a medical consultation.The following information was provided by the initial reporter: "the patient had local redness, swelling and heat pain after intravenous indwelling needle was used on (b)(6) 2020.The nurse immediately removed the indwelling needle after the discovery and did not show any improvement after local hot application.After the attending physician asked the surgeon for consultation, he instructed local wet and hot compress of magnesium sulfate powder, and the local improvement was obvious 1 day later adr# (b)(4).".

Event Description

It was reported that intima-ii y 24gax0.75in prn/ec slm caused an allergic reaction which resulted in a medical consultation.The following information was provided by the initial reporter: "the patient had local redness, swelling and heat pain after intravenous indwelling needle was used on (b)(6) 2020.The nurse immediately removed the indwelling needle after the discovery and did not show any improvement after local hot application.After the attending physician asked the surgeon for consultation, he instructed local wet and hot compress of magnesium sulfate powder, and the local improvement was obvious 1 day later adr# 137610202202011164.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 0063924.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, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: INTIMA-II Y 24GAX0.75IN 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: 11061137
• MDR Text Key: 225826835
• Report Number: 3006948883-2020-01026
• 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: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0063924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention