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

Catalog Number 394945

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd connecta¿ stopcock there where 3 occasions when the injection port had an issue with leakage.

Event Description

It was reported that during use of the bd connecta¿ stopcock there where 3 occasions when the injection port had an issue with leakage.

Manufacturer Narrative

Investigation summary: a sample could not be obtained for evaluation and testing.A device history review was conducted for lot number 8226712.Records show the reported lot was manufactured on 08/30/2018, and determined that this is the fourth instance of leakage occurring in this batch of connecta.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.Investigation conclusion: bd was not able to confirm the customer¿s indicated failure mode because photo or samples were not provided which are necessary to perform better investigation.However, customer reported injection valve leakage; this failure mode was detected in other customer complaints where leakage occurred at the valve port assy.Due to a bad tubing assembly.Engineering team assessed the assembly process finding a worn pin in station 5 that could cause the reported failure mode.This pin is in charge of assembling the gray tubing into the valve housing.Internal risk processes were reviewed and there are proper controls in place to detect product malfunctions.Root cause description: without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.It is possible, based on investigation results to date, for leakage issue (in injection valve) associated to a bad tubing assembly by station 5 of equipment vh59.Rationale: nogales will open capa (#629955) to better support a situation analysis.

• 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: 8241081
• MDR Text Key: 132935001
• Report Number: 9610847-2018-00474
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8226712
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other