MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS1 360 WHITE BLEND; STOPCOCK

Catalog Number 394910

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the connecta plus1 360 white blend was found to be cracked during use on a patient.The following information was provided by the initial reporter: "i have a cracked bd stopcock ref 394910.It has a visible small crack on it that was discovered while in use on a patient.".

Event Description

It was reported that the connecta plus1 360 white blend was found to be cracked during use on a patient.The following information was provided by the initial reporter: "i have a cracked bd stopcock ref 394910.It has a visible small crack on it that was discovered while in use on a patient.".

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Manufacturing has determined that this is not a bd product.

• Brand Name: CONNECTA PLUS1 360 WHITE BLEND
• 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: 9629904
• MDR Text Key: 194705632
• Report Number: 9610847-2020-00015
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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: 394910
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other