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

Catalog Number 2C1008K

Device Problem Crack (1135)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a large volume infusor had a cracked luer connector.This was observed during patient infusion, when connected to a non-baxter luer activated valve.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The lot was manufactured from january 22, 2020 - january 24, 2020.The device was received for evaluation.A visual inspection was performed using the naked eye which observed a non baxter needle attached to the distal luer of the infusor and the tip of the luer has been damaged in which a piece from the luer was cracked and the piece d broken off.The reported condition was verified.The cause of the crack could not be determined; however, the most probable cause is user related or defective distal luer.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: 11916552
• MDR Text Key: 258591047
• Report Number: 1416980-2021-03269
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022512
• UDI-Public: (01)00085412022512
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C1008K
• Device Lot Number: 20A035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: B.BRAUN SAFEFLOW.