MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

Catalog Number 383019

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

Patient Problem Inflammation (1932)

Event Date 09/16/2020

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. Fda device problem code: 2993, fda patient problem code: 1932.

Event Description

It was reported that the patient developed swelling at the bd intima ii¿ iv catheter prn adapter puncture site during the infusion, which was diagnosed as phlebitis. The needle was removed, local symptomatic treatment was performed, and the patient's symptoms were gone by the following day. The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted for treatment due to "femoral neck fracture". On the fourth day of admission, the nurse noticed redness and swelling at the puncture site during infusion at 9 am. The patient reported local pain, which was diagnosed as phlebitis by the attending physician, the disposable indwelling needle immediately removed with local symptomatic treatment, one day later the symptoms was disappeared".

• Brand Name: BD INTIMA II IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10715071
• MDR Text Key: 212446014
• Report Number: 3006948883-2020-00593
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8262024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/21/2020 Patient Sequence Number: 1