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

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8037509, medical device expiration date: 2021-01-31, device manufacture date: 2018-03-28.Medical device lot #: 8100700, medical device expiration date: 2021-03-31, device manufacture date: 2018-05-24.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 during use of the bd connecta¿ stopcock the 3-way stopcock leaked from injection port.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot numbers 8037509 & 8100700.Bd engineers have noted a trend in leakage for 8037509, but this is the only recorded instance occurring in lot 8100700.According to the sampling plan applied for product performance, these lots were accepted and released, with no defects being noted during final assembly or visual inspections.Our quality engineers subjected the devices submitted to leakage testing.The results these test were able identify leakage between the housing and tap junction.This type of nonconformance is caused by worn components in the manufacturing machinery.When worn down, these components can lead to an improper connection between the valve housing and the tubing of the device, causing a leak to occur at this junction.To prevent the reoccurrence of this event, the worn component was replaced on (b)(6) 2018.Bd will continue to track and trend for this issued for this issue.Nogales will open a capa (#629955) not because of the cid as it is ¿no capa required¿ as per cpr-028 based on the severity and occurrence calculation, the reason to open the capa is to better support the exposure to external stakeholders, the focus of the capa will be batch 8037509 and sub-assembly lots related to that batch.

Event Description

It was reported that during use of the bd connecta¿ stopcock the 3-way stopcock leaked from injection port.There was no report of exposure, injury, or medical intervention.

• 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: 8016352
• MDR Text Key: 125608793
• Report Number: 9610847-2018-00352
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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: 394945
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other