MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AMC9668

Device Problem Backflow (1064)

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

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a continu-flo solution set presented a backflow of blood with the key clamp closed.The issue was identified during an unspecified patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured on an unspecified date of september 2021.H10: the actual device was not available; however, retained samples were evaluated.Visual inspection was performed on the retained samples which did not identify any abnormalities that could have contributed to the reported condition.The samples were gravity and leak tested with no issues noted.The reported condition was not verified on the retention samples.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: CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13693677
• MDR Text Key: 286859920
• Report Number: 1416980-2022-00957
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765578038
• UDI-Public: (01)05413765578038
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/08/2022

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: Other
• Device Catalogue Number: AMC9668
• Device Lot Number: 21I04T695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 79 YR
• Patient Sex: Male