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

Catalog Number 394945

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd connecta¿ stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: fluid loss occurs by administration valve.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8180509.Our records show that this is the only 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.A sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It has been reported that one bd connecta¿ stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: fluid loss occurs by administration valve.

Event Description

It has been reported that one bd connecta¿ stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: fluid loss occurs by administration valve.Info add: they informed that the leaks of the bd connecta extender began immediately after the installation of the catheter without any pressure on the infusion.The samples, having biological remains, were eliminated by the institution.They were only used to infuse patients with hydration.

Manufacturer Narrative

The following information has been updated: b.5.Describe event or problem: it has been reported that one bd connecta¿ stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: fluid loss occurs by administration valve.Info add: they informed that the leaks of the bd connecta extender began immediately after the installation of the catheter without any pressure on the infusion.The samples, having biological remains, were eliminated by the institution.They were only used to infuse patients with hydration.

• 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 ; MX
• MDR Report Key: 9242223
• MDR Text Key: 219378633
• Report Number: 9610847-2019-00642
• 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,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8180509
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other