MAUDE Adverse Event Report: BD (SUZHOU) BD INSYTE-A¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382802

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/15/2019

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 part of the device and catheter remained in body of patient with a bd insyte-a iv catheter.The parts were removed from patient.The following information was provided by the initial reporter, translated from (b)(6) to english: when using insyte a, the guide wire and a part of the catheter remained in the patient's body.The remained parts have been already removed.

Event Description

It was reported that part of the device and catheter remained in body of patient with a bd insyte-a¿ iv catheter.The parts were removed from patient.The following information was provided by the initial reporter, translated from japanese to english: when using insyte a, the guide wire and a part of the catheter remained in the patient's body.The remained parts have been already removed.

Manufacturer Narrative

Investigation summary: a sample has not been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.Additionally, a lot number could not be connected to the device identified in the complaint, so bd investigators could not conduct a device history review for this event.

• Brand Name: BD INSYTE-A¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9256224
• MDR Text Key: 164882217
• Report Number: 3006948883-2019-00890
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382802
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other