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

Catalog Number 2B8013

Device Problems Device Contamination with Chemical or Other Material (2944); Improper Chemical Reaction (2952)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph did not reveal sufficient evidence for the presence of particulate matter.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that small white particles were found in a 500ml intravia container.The reporter stated there was one particle approximately 2mm in size, which was of proteinic origin.The bag was filled with aralast np.It was reported that the solution reacted with the plastic bag creating the white particles and causing the solution to turn yellow.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: INTRAVIA CONTAINER EMPTY
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 00705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 00705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5676758
• MDR Text Key: 45836085
• Report Number: 1416980-2016-09684
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• PMA/PMN Number: K964853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 2B8013
• Device Lot Number: UR15I11068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARALAST NP