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

This event occurred during the unspecified date of (b)(6) 2020.Initial reporter's address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the tubing of a sterile repeater pump tube set disconnected.During compounding, the "tubing to the spike popped off ".The set had to be replaced.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction made to g2: report source: company representative, healthcare professional (previously submitted as company representative, consumer, distributor/importer, foreign, healthcare professional).Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured between august 11, 2020 to august 12, 2020.H10: the device was received for evaluation.Unaided eye visual inspection was performed and the tube set tubing with detached spike was identified.By the nature of the sample, no additional tests were performed.The reported condition was verified.The cause of the condition was due to an inadequate or lack of loctite 4601 adhesive being applied at the spike connection to the tubing during the manufacturing process.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: 11253205
• MDR Text Key: 233259602
• Report Number: 1416980-2021-00267
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: 60251709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1