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

Catalog Number 394936

Device Problem Leak/Splash (1354)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 during use of the bd connecta¿ stopcock with extension tubing the cap of the product is leaking.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8212970.Records show the reported lot was manufactured on 04/10/2018, and indicate that this is the only instance of leakage occurring in this batch of connecta.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.Investigation conclusion: the sample that was submitted by the facility was subjected to leakage testing; the results from this experiment were unable to identify any leaks in the device that would have originated under product specifications.Root cause description: based on the investigation, the root cause for this complaint could not be determined at the conclusion of the review.Rationale: bd will continue to track and trend for this issue.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported that during use of the bd connecta¿ stopcock with extension tubing the cap of the product is leaking.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH 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: 8162136
• MDR Text Key: 130475080
• Report Number: 9610847-2018-00421
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 394936
• Device Lot Number: 8212970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other