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 Phlebitis (2004)

Event Date 04/04/2018

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 bd intima ii¿ iv catheter prn adapter caused phlebitis.Furthermore it was reported that "the patient entered into hospital against anti-infection treatment.".

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use? no.Device returned to manufacturer: no.

Event Description

It was reported that bd intima ii¿ iv catheter prn adapter caused phlebitis.Furthermore it was reported that "the patient entered into hospital against anti-infection treatment.".

Event Description

It was reported that bd intima ii¿ iv catheter prn adapter caused phlebitis.Furthermore it was reported that "the patient entered into hospital against anti-infection treatment.".

Manufacturer Narrative

Investigation summary: our investigation was unable to procure either a sample or photo of the affected device.Our investigators reviewed the batch record, raw material process, and sterilization process; no abnormalities were noted in the documentation.There are many factors that can lead to the phlebitis such as chemical phlebitis caused by the infusion of drugs, the repeated infusion into a vein, undetected puncture through vessels, or a patients reaction to the drugs being infused.Unfortunately, without the physical sample for review our investigators could not determine the root cause at this time.

• 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
• MDR Report Key: 7698742
• MDR Text Key: 114329001
• Report Number: 3006948883-2018-00115
• 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,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/18/2020
• Device Catalogue Number: 383019
• Device Lot Number: 7265037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention