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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(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 an unknown particle on its needle.The particle was described as small, difficult to see, silver, and having the appearance of a hair.Patient involvement and the step of setup or therapy during which this was noticed were not reported.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device manufacturing date was between july 24, 2015 and july 28, 2015.The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did identify the presence of particulate matter on the cannula.The cause of the condition could not be determined.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5277245
• MDR Text Key: 33022087
• Report Number: 1416980-2015-43724
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/26/2020
• Device Catalogue Number: 2B8071
• Device Lot Number: GR15F26047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• 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