MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394501

Device Problems Leak/Splash (1354); Retraction Problem (1536)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the connecta q-syte wht connector ring was damaged during use, causing a reflux on the norepinephrine administration route.The patient developed hyptension as a result, and an increase in norepinephrine was prescribed by the doctors.The following information was provided by the initial reporter, translated from (b)(6) to english: twice on 2 different patients and with 2 different caregivers, the connector ring is no longer fixed.This caused a reflux on the norepinephrine administration route.The 2 connectors come from the same batch (defective devices not kept).Classification of the incident : serious deterioration of the health status clinical consequences and current status of the patient or person involved: major hypotension for the patients concerned.Actions taken for the patient regarding the device: incriminated lot set aside pending returns from the supplier.Actions taken in the establishment: declaration of material vigilance.Indeed, doctors prescribed an increase in norepinephrine and asked for closer monitoring.

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9310331.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.During connection, please ensure that the product is connected in accordance with the instructions for use.If the device is connected incorrectly, it can result in damage to the connector.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that the connecta q-syte wht connector ring was damaged during use, causing a reflux on the norepinephrine administration route.The patient developed hyptension as a result, and an increase in norepinephrine was prescribed by the doctors.The following information was provided by the initial reporter, translated from french to english: twice on 2 different patients and with 2 different caregivers, the connector ring is no longer fixed.This caused a reflux on the norepinephrine administration route.The 2 connectors come from the same batch (defective devices not kept).Classification of the incident : serious deterioration of the health status clinical consequences and current status of the patient or person involved: major hypotension for the patients concerned.Actions taken for the patient regarding the device: incriminated lot set aside pending returns from the supplier.Actions taken in the establishment: declaration of material vigilance.Indeed, doctors prescribed an increase in norepinephrine and asked for closer monitoring.

• Brand Name: CONNECTA Q-SYTE WHT
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10610942
• MDR Text Key: 209339856
• Report Number: 9610847-2020-00302
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 394501
• Device Lot Number: 9310331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention