MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.

Catalog Number 2B8011

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One actual sample was received for evaluation.The returned unit was labeled for single use.A visual inspection was performed and it was noticed that the bag had attached a spike.Functional testing was performed, when we tried to remove the spike from the bag, the membrane tube came out of the bag, it was impossible remove the spike.The reported condition was verified for the returned unit.The cause of the condition could not be determined.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.

Event Description

This report summarizes 2 malfunction events.It was reported that an unspecified amount of 150 ml bags were difficult to remove from iv sets at the bag port.This event occurred during use of the device.These events involved patients with no patient consequences.No additional information is available.

• Brand Name: INTRAVIA CONTAINER EMPTY
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8555326
• MDR Text Key: 144988597
• Report Number: 1416980-2019-02312
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00085412003467
• UDI-Public: (01)00085412003467
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2B8011
• Device Lot Number: DR18G24070
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1