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

Catalog Number 383083

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/13/2018

Event Type  Injury  

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 a bd intima-ii¿ closed iv catheter system detached in a pediatric patient.The patient was taken to the hospital for treatment.It was reported that there were multiple hospital visits and transfers, and that the ¿current development positioning: drift to the lungs¿.The outcome has not been reported.

Event Description

It was reported that a bd intima-ii closed iv catheter system detached in a pediatric patient.The patient was taken to the hospital for treatment.It was reported that there were multiple hospital visits and transfers, and that the ¿current development positioning: drift to the lungs¿.The outcome has not been reported.

Manufacturer Narrative

A device history review was conducted for lot number 8017195.Our records show the reported lot was manufactured in february of 2018, and it was determined that this is the only instance of a broken catheter 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.Additionally, based on the submitted photographs, our engineers speculated that the damage was most likely caused by excess pull force.In an attempt to replicate the reported event, our engineers subjected several retention samples to tensile testing; the results of these tests found all of the tested devices to be with product specifications.Unfortunately based on these test results, the root cause for this complaint could not be determined at the conclusion of our review.

• 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: 8091542
• MDR Text Key: 128019076
• Report Number: 3006948883-2018-00286
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: 382903830336
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8017195
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention