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

Catalog Number 394926

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/01/2018

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 with the use of the bd connecta¿ stopcock with extension tubing there was an issue with having to replace 6 connecta due to leakage when replacing the luer lok syringe.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8184832.Our records show that this is the only instance of leakage occurring in this production batch.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported with the use of the bd connecta¿ stopcock with extension tubing there was an issue with having to replace 6 connecta due to leakage when replacing the luer lok syringe.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH EXTENSION TUBING
• Type of Device: CONNECTA
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8348601
• MDR Text Key: 136618767
• Report Number: 9610847-2019-00170
• 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: 03/26/2019

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 Expiration Date: 06/30/2021
• Device Catalogue Number: 394926
• Device Lot Number: 8184832
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other