MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ALL-IN-ONE CONTAINER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number E3MC3801A

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Telephone number: (b)(6).Eighteen samples were received for sample evaluation.A visual inspection revealed that twelve units had solvent smudges on the bag ports, two samples had cloudiness at the white injection site connection (excessive solvent), three samples had a very tiny black spot on the bag, and one sample had a particle inside the pouch under the tpn bag.The black spots on bags were embedded in the bag material as they did not move even when rubbed from both outside and inside of bag.The particle in the pouch seemed to be a glue particle most probable from the pouch sealing machine.There was no evidence of cuts or grazes on/inside the tubing of the middle additive port.Therefore, the reported condition was not verified.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 two all-in-one containers had grazes on and inside of 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: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 7155701
• MDR Text Key: 96222192
• Report Number: 1416980-2017-10091
• Device Sequence Number: 1
• Product Code: FPA
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: E3MC3801A
• Device Lot Number: 17H12V497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Date Manufacturer Received: 12/04/2017
• 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