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

Catalog Number 394605

Device Problem Unintended Ejection (1234)

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

Event Date 08/03/2018

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¿ stopcock leaked during use.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

A device history report was conducted for lot number 8019858, and no abnormalities related to this event were found.This lot was manufactured on 01/25/2018, and this is the only instance of this complication occurring for this lot.According to the sampling plan applied for product performance, this lot was accepted and released with no defects being noted during the final assembly or in the visual inspections of packaged goods.A sample could not be obtained for the purpose of the investigation.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported that the bd connecta stopcock leaked during use.There was no report of exposure, injury, or medical intervention.

• 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: 7844678
• MDR Text Key: 119376332
• Report Number: 9610847-2018-00287
• 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: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 394605
• Device Lot Number: 8019858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other