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

Catalog Number 394951

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 11/08/2018

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 with the use of the bd connecta¿ 3-way stopcock there was an issue with connector damaged, broke off from tubing.

Event Description

It was reported with the use of the bd connecta 3-way stopcock there was an issue with connector damaged, broke off from tubing.

Manufacturer Narrative

A device history review was conducted for lot number 8156505.Our records show the reported lot was manufactured on 06/23/2018 and it was determined 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.Unfortunately the photo provided for evaluation was not sufficient to determine the root cause for this event, and a sample could not be obtained for our evaluation.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd was able to confirm the customer¿s indicated failure mode according photo received but is not able to duplicate the failure mode because was not received the sample which is necessary to perform a better investigation.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.(b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause for manufacturing process cannot be determined, the sample was not received and for the team is difficult determinate the root cause of the failure mode reported.

• Brand Name: BD CONNECTA¿ 3-WAY 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: 8125759
• MDR Text Key: 129321175
• Report Number: 9610847-2018-00406
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 394951
• Device Lot Number: 8156505
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other