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

Catalog Number 394600

Device Problem Leak/Splash (1354)

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

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that the bd connecta¿ stopcock has been found damaged during use.The following has been provided by the initial reporter: 3way stop cock disassembled in the absence of any particular tension on the catheter.Consequence for the patient: discontinuation of norepinephrine, hypotension observed.

Manufacturer Narrative

H.6.Investigation: one picture sample was provided for evaluation by our quality engineer team; however, the reported defect could not be identified through the picture sample alone.As a definite lot number was unknown for this incident, a review of the production history could not be completed.Quality records for the connecta plus3 white product were consulted for tracking and trending purposes, but no issues such as this incident were detected.

Event Description

It has been reported that the bd connecta¿ stopcock has been found damaged during use.The following has been provided by the initial reporter: 3way stop cock disassembled in the absence of any particular tension on the catheter.Consequence for the patient: discontinuation of norepinephrine, hypotension observed.

• 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: 9366747
• MDR Text Key: 191729388
• Report Number: 9610847-2019-00695
• 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: 01/15/2020

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 Catalogue Number: 394600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other