MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394602

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported while using bd connecta¿ stopcock air entered the line and leakage occurred at the connection point.This is report 2 of 2.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: on 19.4.And 20.4.We have noticed an influx of air into the running infusion.19.4 - patient id - (b)(6), female.20.4 - patient id - (b)(6), male.We have also noticed a loss of vasopressor due to leakage at the connection point with a consequent risk to the patient due to a drop in blood pressure.In our opinion, the cause is the poor workmanship of the luer-look connection point, which is already visibly difficult to connect.

Manufacturer Narrative

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

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16935721
• MDR Text Key: 315492867
• Report Number: 9610847-2023-00114
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903946020
• UDI-Public: (01)00382903946020
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2023

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 Catalogue Number: 394602
• Device Lot Number: 3012417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male