MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE; SET, I.V. FLUID TRANSFER

Catalog Number 2B8071

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that a vial-mate adapter leaked.There was no report of patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received for evaluation.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Manufactured 01/29/2014 - 01/30/2014.Evaluation summary: the sample was not available for evaluation; however the customer did return a sample from the same lot.A visual inspection did not identify any malfunctions or abnormalities.The device was functionally tested and was found to function without issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.If additional relevant information is obtained, then a follow-up mdr will be submitted.

• Brand Name: IVT DISPOSABLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1; cleveland MS 38732
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1; cleveland MS 38732
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3936340
• MDR Text Key: 4537212
• Report Number: 1416980-2014-22709
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/19/2018
• Device Catalogue Number: 2B8071
• Device Lot Number: GR13L19027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 07/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2014
• 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