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

Catalog Number MMC3808A

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

It was reported that an oxygen barrier (multilayer) parenteral nutrition container leaked "near the port area".It was further reported that "the port was not sealed to the bag at all as it was loosely attached to the bag".This was observed during inspection.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction d4 lot #: update to 21k16v475 (reported as 21k6v475 on initial).The device was received for evaluation.A visual inspection was done which observed the tube had become disconnected from the bag.The tube is welded to the bag during the manufacturing process.The weld lines were very visible therefore, the welding process was done but fusion was not done between the tube and the bag.Functional testing was not performed for this complaint.The reported condition was verified.The cause of the condition was due to a manufacturing related 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.

• Brand Name: ALL-IN-ONE CONTAINER
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14690346
• MDR Text Key: 294533835
• Report Number: 1416980-2022-03109
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MMC3808A
• Device Lot Number: 21K16V475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1