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

Catalog Number 383033

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Date 05/27/2019

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 was used and the patient had an allergic reaction.This was discovered during use.The following information was provided by the initial reporter: it's noticed that redness, swelling and itchiness on the insertion site "o.5h" after start infusion.The insertion site was treated with "iodov," then symptom improved.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system was used and the patient had an allergic reaction.This was discovered during use.The following information was provided by the initial reporter: it's noticed that redness, swellness and itchy on the insertion site o.5h after start infusion the insertion site was treated with iodov then symptom then improved.

Manufacturer Narrative

Investigation: a sample nor photo was provided for the investigation.At this time a possible root cause can not be determined.Dhr was performed and no abnormalities were observed.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of reaction with lot #8305868 regarding item #383033.

• 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: 8836731
• MDR Text Key: 152503663
• Report Number: 3006948883-2019-00599
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8305868
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention