MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MRC0005MP

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that good permeability of the vein was not achieved with a solution set even though there was good venous return.The blood was returned through the set until it reached the burette.The event was observed during use at the clinic.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8149158
• MDR Text Key: 129907988
• Report Number: 1416980-2018-07729
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MRC0005MP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 71 YR