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

Catalog Number 394971

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd connecta¿ stopcock with valve & extension tubing leaked.No serious injury or medical intervention was reported.

Event Description

It was reported that bd connecta¿ stopcock with valve & extension tubing leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: a sample could not be obtained for evaluation and testing.A device history review was conducted for lot number 8145539.Our records show that this is the only instance of this issue 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.Root cause description: without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.However based on previous investigations and the facilities description of events our engineers speculate that the most likely root cause is an abnormality in the equipment responsible for tubing assembly.Rationale: to prevent a reoccurrence of this event we have retrained our personnel and optimized our manufacturing process to monitor this issue more thoroughly.Bd will continue to track and trend for this issue.Nogales will open a capa (#629955) not because it is required per manufacturing procedure, based on the severity and occurrence calculation, but the reason to open the capa is to better support a situation analysis already opened.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING
• 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: 8180362
• MDR Text Key: 131138393
• Report Number: 9610847-2018-00434
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 394971
• Device Lot Number: 8145539
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other