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

Catalog Number 383453

Device Problem Insufficient Information (3190)

Patient Problem Phlebitis (2004)

Event Date 10/20/2017

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.

Event Description

It was reported that on the second day of infusion using a bd intima ii¿ iv catheter prn adapter the newborn's arm showed signs of phlebitis at the puncture site.

• 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 ; 8015652845
• MDR Report Key: 7037748
• MDR Text Key: 92298887
• Report Number: 3006948883-2017-00093
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2017

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: 12/31/2019
• Device Catalogue Number: 383453
• Device Lot Number: 6355125
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention