MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The lot was manufactured from july 27, 2020 - july 28, 2020.Eleven (11) companion samples were received for evaluation.Unaided visual inspection was performed did not identify any abnormalities that could have contributed to the reported condition.All of the clamps were damage when an excessive force is required to close the clamps.During analysis, two loose tabs broke off inside the closed damaged clamp of 5 samples and 1 loose tab broken off inside the closed damaged clamp of 6 samples.The reported condition was verified.The cause of the condition was due to a supplier manufacturing issue.This issue is being further investigated.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.

Event Description

During evaluation, the clamps of eleven (11) 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were damaged when excessive force was applied when closing the clamps.

• Brand Name: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• 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 60073 ; 2242702068
• MDR Report Key: 10736484
• MDR Text Key: 213200492
• Report Number: 1416980-2020-06648
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: H938737
• Device Lot Number: 60250611
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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