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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported it has ¿happened for the past three weeks¿.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the spikes of an unspecified number of sterile repeater pump tube sets were separated from the tubing; further described as ¿tubing became disconnected at the vial spike and slipping off¿.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from july 29, 2020 - july 30, 2020.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that the vent filter was detached and missing.No other damage was observed during visual inspection.The spike was received attached to the tubing of the returned sample and through manual pull testing it was noted that the spike could not be detached.The reported condition of a detached spike was not verified; however, it was noted that the vent filter was detached and missing.The cause of the missing vent filter could not be determined.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: TUBE SET, STD VOL, STER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11233302
• MDR Text Key: 232158006
• Report Number: 1416980-2021-00188
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: H93811
• Device Lot Number: 60249885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.