MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCKS

Catalog Number 394602

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 08/23/2018

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 nurse found leakage from product where it was broken from connection site during use of the bd connect 3- way stopcock.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the nurse found leakage from product where it was broken from connection site during use of the bd connecta 3- way stopcock.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

A device history review was conducted for lot number 7248905 our records show it was manufactured on 09/29/2018, and determined that this is the only instance of 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.Unfortunately a sample could not be obtained for the purpose of the investigation.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Based on investigation results to date, root cause for manufacturing process cannot be determined.

• Brand Name: BD CONNECTA¿ 3-WAY STOPCOCKS
• 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: 7877729
• MDR Text Key: 120539836
• Report Number: 9610847-2018-00309
• 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,health professional,o
• 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: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 394602
• Device Lot Number: 7248905
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other