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 Skin Inflammation (2443)

Event Date 11/23/2020

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 in the left arm with use of the bd intima-ii¿ closed iv catheter system.The puncture site was treated with a hot compress, but was escalated to a static therapy group consultation when the swelling did not fade and the skin temperature rose.A bedside b-ultrasound was performed and the patient was given conservative medical treatment.The following information was provided by the initial reporter, translated from chinese to english: "with line in the (b)(6) 2020 days left arm superficial vein indwelling needle, found on the evening of 23 local swelling, puncture point to give out immediately, local nurse completed treatment and hot compress, 2 later found swelling did not fade, skin temperature is high, the pain did not improve, please immediately static therapy group consultation, suspend hot compress, bedside b-ultrasound examination clew: swelling of thrombosis is - 4 cm long.Advise affected limb to brake, internal medicine conservative treatment.".

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 0019807.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.

Event Description

It was reported that the patient developed a systemic reaction in the left arm with use of the bd intima-ii¿ closed iv catheter system.The puncture site was treated with a hot compress, but was escalated to a static therapy group consultation when the swelling did not fade and the skin temperature rose.A bedside b-ultrasound was performed and the patient was given conservative medical treatment.The following information was provided by the initial reporter, translated from chinese to english: "with line in the (b)(6) 2020 days left arm superficial vein indwelling needle, found on the evening of 23 local swelling, puncture point to give out immediately, local nurse completed treatment and hot compress, 2 later found swelling did not fade, skin temperature is high, the pain did not improve, please immediately static therapy group consultation, suspend hot compress, bedside b-ultrasound examination clew: swelling of thrombosis is - 4 cm long.Advise affected limb to brake, internal medicine conservative treatment.".

• 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: 11181357
• MDR Text Key: 227807607
• Report Number: 3006948883-2021-00107
• 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: 02/07/2021

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: Health Professional
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0019807
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/07/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention