MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING

Catalog Number 394971

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).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 was reported that bd connecta¿ stopcock with valve & extension tubing leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8151765.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.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 and the complaint is not confirmed.

Event Description

It was reported that bd connecta¿ stopcock with valve & extension tubing leaked.No serious injury or medical intervention was reported.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING
• 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: 8155602
• MDR Text Key: 130178285
• Report Number: 9610847-2018-00420
• 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: 02/07/2019

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: 04/30/2021
• Device Catalogue Number: 394971
• Device Lot Number: 8151765
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other