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

Catalog Number 383406

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

Patient Problems Abscess (1690); Infarction, Cerebral (1771); Dementia (1808); Erythema (1840); Fever (1858); High Blood Pressure/ Hypertension (1908); Swelling (2091); Weakness (2145); Reaction (2414)

Event Date 03/19/2020

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.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system caused an allergic reaction in a patient.The following information was provided by the initial reporter: "on (b)(6) 2020, the patient came to the department of neurology of our hospital for inpatient treatment due to "weakness of the left limb, unclear speech for more than 1 year, and aggravation for more than 10 days".After checking , doctor diagnosed with these questions, 1 cerebral infarction and vascular dementia; 2.Type 2 diabetes mellitus; 3.Hypertension level 3 high risk group; 4.Premature coronary heart disease; 5.Degeneration of the right knee joint; 6.Lumbar disc herniation.On (b)(6), the nurse used closed vein indwelling needle to treat the patient with infusion, and at 21 o 'clock on (b)(6), the patient developed fever, and the body temperature was 38.3¿.The nurse found that the venipuncturing site of the right hand had about 1cm×1cm abscess, which was locally suppurated, and the surrounding skin was red and swollen.The possibility of bacteremia was not excluded.".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 7265024.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 bd intima-ii¿ closed iv catheter system caused an allergic reaction in a patient.The following information was provided by the initial reporter: "on (b)(6) 2020, the patient came to the department of neurology of our hospital for inpatient treatment due to "weakness of the left limb, unclear speech for more than 1 year, and aggravation for more than 10 days".After checking , doctor diagnosed with these questions, 1 cerebral infarction and vascular dementia; 2.Type 2 diabetes mellitus; 3.Hypertension level 3 high risk group; 4.Premature coronary heart disease; 5.Degeneration of the right knee joint; 6.Lumbar disc herniation.On march 16, the nurse used closed vein indwelling needle to treat the patient with infusion, and at 21 o 'clock on march 19, the patient developed fever, and the body temperature was 38.3¿.The nurse found that the venipuncturing site of the right hand had about 1cm×1cm abscess, which was locally suppurated, and the surrounding skin was red and swollen.The possibility of bacteremia was not excluded ".

• 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: 10022064
• MDR Text Key: 193334004
• Report Number: 3006948883-2020-00161
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K143610
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/06/2020
• Device Catalogue Number: 383406
• Device Lot Number: 7265024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other