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

Catalog Number ZMC7401

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 12/02/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) college.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a stopcock in blister pack was cracked which resulted in a leak.This issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, six (6) retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the retained samples.The actual device was not received for evaluation; therefore, a actual device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 18436481
• MDR Text Key: 331895388
• Report Number: 1416980-2023-06893
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: Health Professional
• Device Catalogue Number: ZMC7401
• Device Lot Number: 22K17V495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male