MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the clamps of one-hundred fifty-three (153) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags would not close, further described as "clamp unlocked".It was further reported the clamps were damaged.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: lot manufactured between may 21, 2020 to may 26, 2020.H10: one hundred forty-nine (149) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The clamps were closed with varying degrees of difficulty.The clamps of ten (10) samples were damage after closing.The reported condition was verified.The cause of the condition was due to a supplier manufacturing issue. this issue is being further investigated.The remaining four (4) samples were not received for evaluation; therefore, a device analysis could not be completed for those samples.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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11113927
• MDR Text Key: 225059375
• Report Number: 1416980-2020-08292
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): Y
• PMA/PMN Number: K900585
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: H938740
• Device Lot Number: 60241135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1