MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 10CM BLUE; CONNECTOR

Catalog Number 394997

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2019

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 separation occurred during use with a connecta plus3 10cm blue.The following information was provided by the initial reporter, "bd connecta 10 cm was connected to a peripheral venous catheter placed on a child.Without manipulation (child was under anesthesia in the operation room), the extension of bd connecta separated itself from the luer-lok of the bd connecta thread it was connected to.".

Event Description

It was reported that separation occurred during use with a connecta plus3 10cm blue.The following information was provided by the initial reporter."bd connecta 10 cm was connected to a peripheral venous catheter placed on a child.Without manipulation (child was under anesthesia in the operation room), the extension of bd connecta separated itself from the luer-lok of the bd connecta thread it was connected to.".

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided lot number 9039992 and the review did not reveal any detected abnormalities during the production process that could have contributed to the reported incident.To further investigate this issue, one physical sample was provided for evaluation by our quality team.Through inspection of the sample, the tubing was observed separated from the product with signs of silicone on the tubing.It has been determined that this incident was a result of a manufacturing process error, in which the tubing was not properly assembled to the luer connection as the sensor within the manufacturing equipment was not properly connected.In response to this incident, the related equipment has been fixed and its proper function has been verified.Our quality team will continue to monitor the production process for this type of defect and other emerging trends.

• Brand Name: CONNECTA PLUS3 10CM BLUE
• Type of Device: CONNECTOR
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9525705
• MDR Text Key: 192062432
• Report Number: 9610847-2019-00772
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 394997
• Device Lot Number: 9039992
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other