MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND EVACUATED CONTAINER; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number 1A8504

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that an unspecified amount of evacuated containers were torn.This event occurred before use.There was no patient involvement.No additional information is available.

• Brand Name: EVACUATED CONTAINER
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; cleveland MS
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8558164
• MDR Text Key: 145113606
• Report Number: 1416980-2019-02348
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00085412046167
• UDI-Public: (01)00085412046167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1A8504
• Device Lot Number: ASKU
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1