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

Catalog Number 2C1154KP

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/09/2021

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 multirate infusor was torn.This was observed prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Device manufactured between october 22, 2019 to october 23, 2019.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.Visual inspection was performed using the naked eye which observed a large hole (torn) in the primary packaging.The device inside the packaging was examined and no issues were noted.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause may potentially be related to the handling of the product during unpacking.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: 12418270
• MDR Text Key: 270181806
• Report Number: 1416980-2021-05424
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081397
• UDI-Public: (01)00085412081397
• Combination Product (y/n): Y
• PMA/PMN Number: K011317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1154KP
• Device Lot Number: 19K028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1