MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8301

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device was manufactured at one of the two following manufacturing sites: (b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that multiple air bubbles and leakage of blood was observed while using a one-link non-dehp standard bore catheter extension set and a non-baxter iv (intravenous catheter).This was observed during flash back of blood when a 22-guage saline lock was initiated.Saline lock was flushed well but continued to leak air and drip blood from the connection site.A new connection was put in place but continued to leak blood.As a result, the saline lock and needle hub were removed and the patient¿s iv was replaced to continue with the therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing and a crack was observed in the female luer.Resulting in a leak.The reported condition was verified.The cause of the condition was material due to non conformance product from the supplier.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11032486
• MDR Text Key: 222713913
• Report Number: 1416980-2020-07895
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7N8301
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD INSYTE AUTOGUARD CATHETER