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

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: in the process of treating the patient, the nurse found that the connection part was slightly damaged with bleeding, so she removed the needle and comforted the patient, and re-punctured.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8305867.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.Additionally, although a sample was not received for the purpose of our investigation, 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.

Event Description

It was reported that leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: in the process of treating the patient, the nurse found that the connection part was slightly damaged with bleeding, so she removed the needle and comforted the patient, and re-punctured.

• 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: 10021208
• MDR Text Key: 194647934
• Report Number: 3006948883-2020-00159
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

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 Expiration Date: 12/08/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8305867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other