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

Catalog Number 2B8114

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: baxter received one used sample for evaluation.The sample was received with clear solution inside the fluid path and black tape over the bag.Visual inspection did not reveal any defects.An underwater leak test was performed, and the device failed.The reported condition was verified.The cause of the condition was not determined.A capa has been initiated to investigate this issue.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

It was reported that an all-in-one container empty eva container leaked 80 grams of immune globulin.The location of the leak was identified to be from a slash two inches from the port.This was identified during set-up.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).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 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3; po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4097829
• MDR Text Key: 12389767
• Report Number: 1416980-2014-31952
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2019
• Device Catalogue Number: 2B8114
• Device Lot Number: UR14D15095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2014
• 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