MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND MINIBAG PLUS CONTAINER; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Catalog Number 2C4950

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a mini-bag plus docking assist tool had part of its plastic vial adaptor nest break off.The reporter stated that this resulted in its screws being exposed which caused the vial to break when the tool was used.There was no patient involvement as this occurred before patient use.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection of the docking tool noted that the plastic on the cradle where the vial is assembled to the vial adapter and bag is broken causing the metal screws to be exposed.The exposed metal on the tool hit the glass vial, causing it to break.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINIBAG PLUS CONTAINER
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• 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: 5505740
• MDR Text Key: 40526482
• Report Number: 1416980-2016-05384
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/12/2016

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: 2C4950
• Device Lot Number: 070952678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1