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 Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

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 fluid leaked from the bd connecta¿ stopcock during aspiration.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: a sample was provided for the purpose of aiding in our quality engineer's investigation.Although, leakage testing could not identify the point of leakage in the returned device, it was found that similar situations were caused by a worn component in the manufacturing machinery failing to properly connect the valve housing with the tubing of the device.The worn component was replaced to prevent the reoccurrence of this event.A device history review was conducted for lot number 8037509, our records show it was manufactured february 2, 2018, and determined that this is the only instance of either air bubbles or leakage occurring in this lot.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 of packaged goods.Investigation conclusion: based on investigation results to date, root cause was associated to a bad tubing assembly by station 5 of equipment vh59.The team implemented corrective actions to prevent reoccurrence.

Event Description

It was reported that fluid leaked from the bd connecta¿ stopcock during aspiration.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: 7869881
• MDR Text Key: 120250874
• Report Number: 9610847-2018-00305
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8037509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other