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 Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Twelve actual samples and ninety-eight companion samples were received for evaluation.Visual inspection revealed five of the actual samples had an indentation on the middle additive port.These five samples were filled with air and leak tested under water; no leaks were found.This issue is classified as a cosmetic defect which does not lead to a functionality issue.The reported condition was not verified.Visual inspection was performed on the remaining seven actual samples and the companion samples and did not identify any abnormalities that could have contributed to the reported condition.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 an unspecified quantity of 250ml eva bags had splits in the tubing of the middle additive port.There was no patient involvement.No additional information is available.

• 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; ni; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7143454
• MDR Text Key: 95658181
• Report Number: 1416980-2017-09979
• 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: Other
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: E3MC3801A
• Device Lot Number: 17G14V161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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