MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number J2C1711

Device Problem Crack (1135)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a small volume infusor had a "scar" (not further specified) on the tubing during use of the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to d5: operator of device: patient/consumer (previously submitted as health professional).H4: the lot was manufactured between december 01, 2020 - december 02, 2020.H10: the device was received for evaluation.Visual inspection was performed and a dark brown particle, measured to be 2.94 mm long and 1.80 mm wide was observed embedded in the material of the tubing line.The particle was not in the fluid path because it was embedded in the material of the tubing line.The particle was identified to be polyvinyl chloride (pvc) material via ftir test.Pvc is the raw material of the tubing line.Fragment of burnt pvc (dark brown particle) can potentially be embedded in the material of the tubing during the manufacture of the device component.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12553820
• MDR Text Key: 273998612
• Report Number: 1416980-2021-06007
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412092706
• UDI-Public: (01)00085412092706
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: J2C1711
• Device Lot Number: 20N039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.