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

Catalog Number 383078

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/03/2019

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 during use of the bd intima-ii¿ closed iv catheter system there was blood leakage at septum after successful puncture.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it was found blood leakage at septum after puncture successfully.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system there was blood leakage at septum after successful puncture.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: it was found blood leakage at septum after puncture successfully.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8305840.Our records show that this is the third instance of this issue occurring in this production batch.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.Our investigators noted a small crack was found during leakage testing that was located on the adapter.The returned product's swage dimensions were measured by our team and found to be within product specifications.However according to previous investigations, through a variance in the autoline's swage pressure it is possible for the machine to apply excess force to the device during assembly, allowing for the resulting crack to form in the device.Currently, we are conducting a long term study, capa#642738, to determine the root cause for this event, but we are addressing the issue through the implementation of manual inspections for cracks in the adapter head, and we are further optimizing our swaging process by reducing depth requirements.

• 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: 8550179
• MDR Text Key: 145113580
• Report Number: 3006948883-2019-00298
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: 382903830787
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/11/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8305840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other