MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 394600

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: 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 during use of the bd connecta¿ stopcock there was a loose connection.

Manufacturer Narrative

A device history review was conducted for lot number 8005644.Our records show the reported lot was manufactured on 01/17/2018, and determined that this is the only instance of this issue occurring in this batch of connecta.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 during our review of the sample submitted by your facility, our engineers found the device to be functioning as expected, as the returned units remained successfully connected during course of functional testing.Our engineers have noted that the only known way to detach the luer connector is through the over-tightening of the component.Unfortunately based on our findings, the root cause for this complaint could not be determined at the conclusion of our review; bd will continue to track and trend for this issue.Customer reported difficult insertion/disconnection/difficult to operate, however, samples have been functional showing no problems.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.(b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause for manufacturing process cannot be determined.

Event Description

It was reported that during use of the bd connecta stopcock there was a loose connection.

• Brand Name: BD CONNECTA¿ STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8101613
• MDR Text Key: 128566540
• Report Number: 9610847-2018-00396
• Device Sequence Number: 1
• Product Code: FMG
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 394600
• Device Lot Number: 8005644
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other