MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO IVT DISPOSABLE; CONTAINER, I.V.

Catalog Number 2B8019

Device Problem Failure to Disconnect (2541)

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

Event Type  malfunction  

Event Description

It was reported that an intravia empty container would not disconnect from an unspecified set.This occurred during infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this 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: IVT DISPOSABLE
• 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: 4940385
• MDR Text Key: 6638480
• Report Number: 1416980-2015-30202
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2020
• Device Catalogue Number: 2B8019
• Device Lot Number: UR15C09099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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