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

Catalog Number 394901

Device Problem Packaging Problem (3007)

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

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

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's individual packaging was open.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that the bd connecta¿ plus stopcock's individual packaging was open.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number v, our records show it was manufactured on 08/05/2017, and determined that this is the only instance of a damaged packaging 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.The facility was able to submit a physical sample and a photograph for evaluation; to address the damage observed in the returned device bd engineers reviewed the packaging process.During the review it was noted that the misalignment between the top and bottom webbing could replicate the damage observed in the sample.This is the mostly likely root cause for the event reported by the facility.In response to this event an aluminum guide has been installed on the packaging machine to avoid future misalignments.Bd will continue to track and trend for this issue.

• Brand Name: BD CONNECTA¿ PLUS 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: 7901362
• MDR Text Key: 121761329
• Report Number: 9610847-2018-00310
• 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: 10/18/2018

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: 06/30/2020
• Device Catalogue Number: 394901
• Device Lot Number: 7209634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 09/03/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other