MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number 2C6251

Device Problems Crack (1135); Air/Gas in Device (4062)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported that a crack was observed in the housing of a four-way large bore stopcock which resulted in an air leak into the tubing.This was identified during priming.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Lot #: suspected lot number: dr22g13062 and dr22d27031 should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction b5: remove statement: ¿this was identified during priming¿ (as stated in the initial report) and change to ¿identified after priming¿.Add further description of the event (omitted on initial): the iv (intravenous) tubing with the extension tubing was attached to a patient iv and opened.It had previously been primed with unspecified iv fluid.It was noted immediately that the tubing had air in it.The iv was stopped.Minimal to no air was introduced (0.5ml) to the patient.The volume in this extension set is 4.1 ml.The entire length of this set was filled with air as a result of the housing being compromised.D5: operator of device: (remove other) and change to health professional.H10: the user facility submitted medwatch (b)(4) for this event.H4: the suspected lot # dr22g13062 was manufactured on 07/14/2022.H4: the suspected lot # dr22d27031 was manufactured on 05/07/2022.H10: a batch review was conducted on the suspected lot numbers and there were no deviations found related to this reported condition during the manufacture of either 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 AND I.V. SOLUTION ADMINISTRATION SETS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16208594
• MDR Text Key: 308293479
• Report Number: 1416980-2022-07453
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: Health Professional
• Device Catalogue Number: 2C6251
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• 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 Weight: 13 KG