MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 7 CM WHITE BLEND; STOPCOCK

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 connecta plus3 7 cm white blend experienced leakage.The following information was provided by the customer: during the infusion a fluid leak was detected from injection.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8250928.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.Additionally, our engineers were unable to duplicate this event through the leakage testing of the submitted device.However based on previous investigations into this issue and a subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.Capa#629955 was opened.Based on investigation results to date, for leakage issue (in injection valve) root cause was associated to a bad tubing assembly by station 5 of equipment vh59.

Event Description

It was reported that the connecta plus3 7 cm white blend experienced leakage.The following information was provided by the customer: during the infusion a fluid leak was detected from injection.

• Brand Name: CONNECTA PLUS3 7 CM 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
• MDR Report Key: 8489884
• MDR Text Key: 145942556
• Report Number: 9610847-2019-00276
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8250928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other