MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC9618

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was received for evaluation.Visual inspection revealed that the set was sealed partially by the packaging.Underwater pressure testing identified a leak at the location where the set was sealed by the packaging machine.The reported condition was verified.The cause was determined to be due to a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a flogard iv solution set was leaking from a slit in the tubing.This occurred during priming with normal saline.There was no patient involvement.No additional information is available.

• Brand Name: SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 5555705
• MDR Text Key: 42153189
• Report Number: 1416980-2016-06772
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: EMC9618
• Device Lot Number: 15F11V827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• 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