MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H93811

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that the unspecified quantity of sterile repeater pump tube sets leaked.During compounding, "the connection of the filter does not attach properly and falls during use" and the hose leaked.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The event occurred (b)(6) 2022.Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured from april 20, 2021 - april 21, 2021.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUBE SET, STD VOL, STER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15412281
• MDR Text Key: 302731034
• Report Number: 1416980-2022-04786
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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 Expiration Date: 03/31/2024
• Device Catalogue Number: H93811
• Device Lot Number: 60291349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/11/2022
• 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