MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ALL-IN-ONE CONTAINER; CONTAINER, I.V.

Catalog Number E3MC3801A

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that four (4) 250ml eva bags were damaged.The damage was further described as scuffs, grazes, and cuts to the port walls of the bags.The damaged was discovered before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Four (4) samples were received for evaluation.Two samples were found to have an indentation on the additive port, the third sample had solvent smudges on the additive port, and the fourth sample had a tiny black particulate matter on the additive port.The indentation on the port and the solvent smudges were confirmed as cosmetic defects that will not lead to a device functionality issue.The tiny black particle was determined to be caused during printing of the bag with ink during manufacturing.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.

• Brand Name: ALL-IN-ONE CONTAINER
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7247943
• MDR Text Key: 99231613
• Report Number: 1416980-2018-00601
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: E3MC3801A
• Device Lot Number: 17H12V497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1