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

Catalog Number 394995

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that connecta plus3 10cm white tubing was loose.The following information was provided by the initial reporter: i would like to make a formal complaint about the following 3-way valve: last friday, an incident with this valve occurred at the intervention radiology where the tubing came loose from the luer lock connection point.This happened again last monday.The relevant lot number has been quarantined in this department and replaced by another lot number.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 2/22/2021 h.6.Investigation: a device history record review was completed for provided lot number 0129551.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one-hundred and thirty-three samples were returned for evaluation by our quality engineer team.The samples were tested for detachment and eleven of the units were found to be lacking dioxolane.The maintenance records were evaluated for the dates of manufacture for this lot.The maintenance records revealed that a damaged component was detected and replaced upon detection.This damaged component could have contributed to a poor assembly between the tubing and fitting components.However, the device history record review did not reveal any detected abnormalities after the resolution of the maintenance defect.See h.10.

Event Description

It was reported that connecta plus3 10cm white tubing was loose.The following information was provided by the initial reporter: i would like to make a formal complaint about the following 3-way valve: last friday, an incident with this valve occurred at the intervention radiology where the tubing came loose from the luer lock connection point.This happened again last monday.The relevant lot number has been quarantined in this department and replaced by another lot number.

• Brand Name: CONNECTA PLUS3 10CM WHITE
• 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: 11009561
• MDR Text Key: 222019045
• Report Number: 9610847-2020-00411
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 394995
• Device Lot Number: 0129551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1