MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB

Catalog Number 394910

Device Problems Material Separation (1562); Connection Problem (2900)

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

Event Date 10/08/2018

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 bd connecta¿ plus stopcock with 4-way 360° tap rotation and white tab didn't connect properly and separated from the syringe during use.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

A device history review was conducted for lot number 6060753.Our records show the reported lot was manufactured on 03/06/2016, and determined that this is the first 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 of packaged goods.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.Based on investigation developed, the nogales team cannot confirm the defect because for this specific complaint, the customer didn¿t provide sample for evaluation or photo to evaluate failure mode reported, which is essential to perform a better investigation.

Event Description

It was reported that the bd connecta plus stopcock with 4-way 360° tap rotation and white tab didn't connect properly and separated from the syringe during use.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB
• 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: 8019469
• MDR Text Key: 125647701
• Report Number: 9610847-2018-00359
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 394910
• Device Lot Number: 6060753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other