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

Catalog Number H93811

Device Problem Disconnection (1171)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a sterile repeater pump tube set dislodged during use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: (b)(6) , 2020 - (b)(6) , 2020.H10: 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.

• Brand Name: TUBE SET, STD VOL, STER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12211561
• MDR Text Key: 262935408
• Report Number: 1416980-2021-04496
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• 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: 08/20/2021

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: 07/31/2023
• Device Catalogue Number: H93811
• Device Lot Number: 60254790
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.