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

Catalog Number 383014

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/15/2020

Event Type  malfunction  

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 the bd intima-ii¿ closed iv catheter system leaked blood during the patient's "full abdominal ct examination".The catheter's indwelling needle was adjusted for a "high-pressure injection rate to 3.0 units per second".The needle was removed and blood vessel "pressed" to stop the bleeding, and the ct examination rescheduled as a result.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, the patient underwent a full abdominal enhanced ct examination in the radiology department of our hospital.The nurse used the closed venous indwelling needle to indwell and adjust the high-pressure injection rate to 3.0 units per second.During the ct examination, the patient's indwelling needle position extensive bleeding, suspend ct examination, removed the indwelling needle, pressed the blood vessel to stopped bleeding, and rescheduled the ct examination after comfort the patient's mood.".

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system leaked blood during the patient's "full abdominal ct examination".The catheter's indwelling needle was adjusted for a "high-pressure injection rate to 3.0 units per second".The needle was removed and blood vessel "pressed" to stop the bleeding, and the ct examination rescheduled as a result.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2020, the patient underwent a full abdominal enhanced ct examination in the radiology department of our hospital.The nurse used the closed venous indwelling needle to indwell and adjust the high-pressure injection rate to 3.0 units per second.During the ct examination, the patient's indwelling needle position extensive bleeding, suspend ct examination, removed the indwelling needle, pressed the blood vessel to stopped bleeding, and rescheduled the ct examination after comfort the patient's mood.".

Manufacturer Narrative

H.6.Investigation summary a device history review was conducted for lot number 9119997.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.H3 other text : see section h.10.

• 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: 9945645
• MDR Text Key: 194643860
• Report Number: 3006948883-2020-00126
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Catalogue Number: 383014
• Device Lot Number: 9119997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other