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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a vial mate adapter leaked.The reporter stated that it was difficult to get the unspecified reconstituted drug back into the solution bag.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of baxter's investigation, if additional relevant information is obtained, 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: 3907091
• MDR Text Key: 4517437
• Report Number: 1416980-2014-21088
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Catalogue Number: 2B8071
• Device Lot Number: GR14A10027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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