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

Catalog Number 394602

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bd connecta¿ stopcock was damaged and leaked.The following information was provided by the initial reporter: the patient experienced a drop in blood pressure at 2:26 on (b)(6) 2023, during which norepinephrine bitartrate was pumped intravenously.The nurse on duty found a crack in the infusion tee connected through the central vein, resulting in drug leakage.A new infusion tee was immediately replaced, and the patient's blood pressure returned to normal.

Manufacturer Narrative

H6: investigation summary: it was reported a crack in the infusion tee connected through the central vein resulted in drug leakage.As a sample was not returned, a thorough sample investigation could not be completed.Damages like these on the stopcock housing do not occur in our production.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.A device history record review was completed for provided material number 394602, lot 2084624.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Bd was not able to confirm the customer's indicated failure mode of component damage - leak.

Event Description

It was reported that the bd connecta¿ stopcock was damaged and leaked.The following information was provided by the initial reporter: the patient experienced a drop in blood pressure at 2:26 on (b)(6) 2023, during which norepinephrine bitartrate was pumped intravenously.The nurse on duty found a crack in the infusion tee connected through the central vein, resulting in drug leakage.A new infusion tee was immediately replaced, and the patient's blood pressure returned to normal.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16873512
• MDR Text Key: 314640131
• Report Number: 9610847-2023-00096
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394602
• Device Lot Number: 2084624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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