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

Catalog Number 383012

Device Problem Leak/Splash (1354)

Patient Problem Skin Tears (2516)

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 while using the bd intima-ii¿ closed iv catheter system there was leakage.The following was recieved by the initital reporter: on (b)(6) 2023, when an outpatient was undergoing enhanced ct, the high-pressure syringe alarmed.The technician checked and found blood oozing from the membrane of the indwelling needle and the pipeline burst.

Event Description

It was reported that while using the bd intima-ii¿ closed iv catheter system there was leakage.The following was received by the initial reporter: on (b)(6) 2023, when an outpatient was undergoing enhanced ct, the high-pressure syringe alarmed.The technician checked and found blood oozing from the membrane of the indwelling needle and the pipeline burst.

Manufacturer Narrative

H6: investigation summary: in response to the event reported a device history review was conducted for lot number 91230640.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.Based on your description of the event, our engineers were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd pegasus is an infusion only device and is not rated for high pressure injections.Bd encourages the review of the instructions for use included with all pegasus units; bd will continue to track and trend for this issue.

• 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
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17294907
• MDR Text Key: 318845671
• Report Number: 3014704491-2023-00337
• 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: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383012
• Device Lot Number: 1230640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/23/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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