MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET

Catalog Number ZMC7401

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a stopcock in blister pack would not connect to the infusion end that was connected to the venous indwelling needle which resulted in a leak.This was observed during patient infusion; when preparing the venous access before operation.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16209812
• MDR Text Key: 308160465
• Report Number: 1416980-2022-07454
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 05413760157153
• UDI-Public: (01)05413760157153
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ZMC7401
• Device Lot Number: 21E07V462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Date Device Manufactured: 05/06/2021
• 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
• Treatment: VENOUS INDWELLING CATHETER
• Patient Age: 48 YR
• Patient Sex: Female