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

Catalog Number 2C2702K

Device Problem Component Missing (2306)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter last name - e1: initial reporter address - (b)(6).E1: initial reporter city - e1: initial reporter state - should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the sterility cap of a small volume infusor was missing.The missing cap was discovered during setup prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufacture date ¿ the lot was manufactured between april 3-5, 2023.The device was received not in its original unopened packaging for evaluation.A visual inspection was performed, and it was noted that the fill port cap was missing from the infusor.The reported condition was verified.The cause of the reported condition could not be determined as the device was not returned in its original unopened baxter package.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; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18707181
• MDR Text Key: 335442595
• Report Number: 1416980-2024-00566
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579368
• UDI-Public: (01)00085412579368
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: Health Professional
• Device Catalogue Number: 2C2702K
• Device Lot Number: 23D002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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