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

Catalog Number 394945

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/26/2019

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 before use of the bd connecta¿ stopcock the tubing was kinked and could not be straightened out.The following information was provided by the initial reporter: kink in the tube which cannot be straightened out to use.The tube is so small trying to straighten it does not work.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8281712.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.Based on their evaluation of the submitted device and our manufacturing process, our engineers determined that the most likely root cause for this non-conformance is incorrect alignment of the manufacturing station.The component of the manufacturing station that was out of alignment has been adjusted accordingly.

Event Description

It was reported that before use of the bd connecta¿ stopcock the tubing was kinked and could not be straightened out.The following information was provided by the initial reporter: kink in the tube which cannot be straightened out to use.The tube is so small trying to straighten it does not work.

• Brand Name: BD CONNECTA¿ 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 ; MX
• MDR Report Key: 8800767
• MDR Text Key: 152786354
• Report Number: 9610847-2019-00471
• Device Sequence Number: 1
• Product Code: LHI
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8281712
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other