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

Catalog Number 2B8071

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation: 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 received for evaluation.Visual inspection showed no defects.The device was connected to a solution bag and vial for functional testing with no particulate matter observed.The reported problem was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Medwatch form received from fda with report number (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vial-mate reconstitution device had particulate matter within it.After the vial (non-baxter product) was attached to the sodium chloride solution bag with the vial-mate device a dark grey particulate was observed in the solution bag.The customer stated that the particulate matter was the membrane of the vial.The customer stated that they previously used filters to prevent this from occurring but have since discontinued filter use.This occurred during use.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Manufacture date: 9/20/13-9/24/13.The device has been received by baxter and is currently under evaluation.Upon completion of the device evaluation, or 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: 4003325
• MDR Text Key: 12392434
• Report Number: 1416980-2014-26184
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2014

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: 09/11/2018
• Device Catalogue Number: 2B8071
• Device Lot Number: GR13I11037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 08/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/06/2014; 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SODIUM CHLORIDE SOLUTION BAG