MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK

Catalog Number 394602

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/09/2018

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 connecta¿ 3-way stopcock broke during use.

Manufacturer Narrative

A device history review was conducted for lot number 8068922.Our records show the reported lot was manufactured in 05/20/2017; it was 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.A photo was submitted for evaluation, but it was not able to assist our engineers in determining the root cause for this event or its relation to the manufacturing process.Bd was not able to duplicate or confirm the customer¿s indicated failure mode, because the sample showed in the picture as broken, is not part of the part number of bd nogales site.Customer reported broken issues; however, only photo was available and not physical sample for evaluation which is essential to perform a better investigation.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.Process (b)(4) and process (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.

Event Description

It was reported that the bd connecta 3-way stopcock broke during use.

• Brand Name: BD CONNECTA¿ 3-WAY 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: 8125897
• MDR Text Key: 129320557
• Report Number: 9610847-2018-00403
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

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: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 394602
• Device Lot Number: 8068922
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other