MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101025

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was particulate matter (pm) was observed within a cartridge blood set.The pm was further described as a couple of spots inside the device.The pm was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Lot number: 1000203119.The actual device, two photographs of the sample and eight retained samples were received for evaluation.Visual inspection of the retention samples did not identify any abnormalities that could have contributed to the reported condition.Visual inspection of the actual sample and provided pictures showed two black spots, one stationary and one floating inside the bloodline.A ftir analysis (fourier transform infrared spectroscopy) was performed and, as result, the black spots were identified as burnt plastic material (pvc).The reported condition was verified.A device history review revealed no issues that could have caused or contributed to the reported issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition was not determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 8210378
• MDR Text Key: 131900558
• Report Number: 8030638-2018-00025
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1