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

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified quantity of access sets leaked at the stop cock connection site.It was further stated that blood was coming from the stopcock area and upon further examination the connection site was found to be "loose".There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: upon further investigation, it was determined that this report is a duplicate of manufacturers report # 1416980-2021-06026.All investigation activities will be captured under mfg.Report #1416980-2021-06026.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12617363
• MDR Text Key: 275958269
• Report Number: 1416980-2021-06215
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/11/2021
• 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