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

Catalog Number 394600

Device Problem Disconnection (1171)

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

Event Date 11/14/2018

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 during use of the bd connecta¿ stopcock there was repeated episodes of spontaneous disconnection with the three-way.

Manufacturer Narrative

A device history review was conducted for lot number 8159952.Our records show the reported lot was manufactured on 06/18/2018, and determined 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.Unfortunately 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.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported disconnection-separates, however, photos or samples were not received which are necessary to perform a better evaluation.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.

Event Description

It was reported that during use of the bd connecta stopcock there was repeated episodes of spontaneous disconnection with the three-way.

• 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: 8135269
• MDR Text Key: 129582021
• Report Number: 9610847-2018-00410
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 394600
• Device Lot Number: 8159952
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other