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

Catalog Number MRC0001MP

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a plexitron solution administration set leaked during priming.A hole was observed in the injection site of the y side.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and ripped y-site tubing was observed.The reported condition was verified.The cause of the reported condition was an assembly issue due to excess solvent.A nonconformance has been opened to address this 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: PLEXITRON SOLUTION ADMINISTRATION 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: 7446796
• MDR Text Key: 106040557
• Report Number: 1416980-2018-02280
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141305553
• UDI-Public: (01)07707141305553
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

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 Expiration Date: 12/31/2022
• Device Catalogue Number: MRC0001MP
• Device Lot Number: SE17LO9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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