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

Catalog Number J2C1711

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there were two cut marks on the tubing of a small volume infusor.This was observed during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from may 17,2022 to may 19, 2022.H10: the actual device was received for evaluation with fluid in the bladder.Visual inspection was performed using the naked eye which noted two marks located on the tubing line.Closer examination of the marks suggested the two marks were not "cut" marks, but rather indentations from an unknown object.The reported condition of cuts on the tubing was not verified, however, damage due to indentations was verified.The cause of the condition could not be determined, however, this issue would not be a breach in the sterile pathway and would most likely be associated with a delay of therapy.As specialty therapy devices are not intended for critical/life sustaining medication, the expected harm for delay of therapy would be negligible and therefore, unlikely to cause harm.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
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16681422
• MDR Text Key: 312761876
• Report Number: 1416980-2023-01553
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412092706
• UDI-Public: (01)00085412092706
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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 Catalogue Number: J2C1711
• Device Lot Number: 22E025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1