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.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• 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
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• 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

• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 394501
• Device Lot Number: 9310331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/30/2020 Patient Sequence Number: 1