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

Catalog Number EMC7406U

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2015

Event Type  malfunction  

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.

Event Description

It was reported that a vialmate could not be activated with a vial of piperacillin/tazobactam (baxter product).This occurred during reconstitution.The reporter stated that due to this issue, they were unable to get solution into the vial.There was no patient involvement.No additional information is available.

• Brand Name: IVT DISPOSABLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5035775
• MDR Text Key: 24313051
• Report Number: 1416980-2015-33981
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/04/2015

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: Health Professional
• Device Catalogue Number: EMC7406U
• Device Lot Number: 15C01V517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1