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 11/19/2020

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 separated on 2 occasions.The following information was provided by the initial reporter: just happened again.This time it concerned a scan with a lower injection speed (3ml/s) than in the 2 previous cases (6 and 6.5ml/s).The psi that has been reached is well captured this time and can be seen on the photo (80-90psi) and not that high at all.Fortunately, this patient did not have to undergo the examination again.2x more, this time with a pink venflon (20g) of the same brand (vasofix).The psi has risen to 80 this time.(we have a pressure limit of 225psi).

Event Description

It was reported that connecta plus3 10cm white separated on 2 occasions.The following information was provided by the initial reporter: just happened again.This time it concerned a scan with a lower injection speed (3ml / s) than in the 2 previous cases (6 and 6.5ml / s).The psi that has been reached is well captured this time and can be seen on the photo (80-90psi) and not that high at all.Fortunately, this patient did not have to undergo the examination again.2x more, this time with a pink venflon (20g) of the same brand (vasofix).The psi has risen to 80 this time.(we have a pressure limit of 225psi).

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 12/22/2020 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, samples were returned for evaluation by our quality engineer team.One-hundred and thirty-three samples were tested for leakage, however, none of the samples revealed any negative results through testing.It is recommended that the instructions for use are closely followed when using the connecta product.The design specifications for this product stipulate that they are designed to withstand infusion therapy and hemodynamic monitoring pressure only.See h.10.

• 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: 11024609
• MDR Text Key: 222039775
• Report Number: 9610847-2020-00417
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/22/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1