MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRACASCULAR CATHETER

Catalog Number 383336

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

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 saf-t-intima¿ iv catheter safety system adapter separated at the connection site and went missing during medical examination after the infusion.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: the actual sample was received for the purpose of our investigation, representative samples were also included.The investigators were able to observe the reported failure mode in the actual sample provided, this sample arrived without an adapter and the pvc tubing appeared to not be included in the assembly of the adapter.This issue was not among the representative samples provided.Representative sample was tested and met with acceptance criteria according (b)(4).Additionally the device history report for lot number 6308782 was reviewed, no related abnormalities were found.Material number 383336 for lot 6308782 was manufactured on 11-24-2016.According to the sampling plan applied for product performance, this lot was accepted and released.Investigation conclusion: based on the results of our investigation to date, the root cause is most likely caused by an abnormality occurring during the manual assembly of the device where the pvc was not correctly placed within the wedge.An auto tubing assembly machine is in the process of completing validation for use in the manufacturing line.The inclusion of this machine will greatly mitigate the possibility of reoccurrence for this failure mode.Bd will continue to track and trend for this issue.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRACASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7443362
• MDR Text Key: 106160852
• Report Number: 9610847-2018-00114
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383336
• Device Lot Number: 6308782
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other