MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE, SET, STD VOL, UNIV ENDS,; SET, I.V. FLUID TRANSFER

Catalog Number	H93821
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot was manufactured between april 01, 2019 and april 02, 2019.Three actual samples were received for evaluation.Visual inspection was performed and the bottom seal was opened on all three samples.The reported condition was verified.The cause of the condition could not be determined.The remaining sample was not received for evaluation; therefore, a device analysis could not be completed.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 or Problem Description
It was reported that the wrapper seals of four units of fluid transfer tube sets were found to be opened.This was identified during testing.There was no patient involvement.No additional information is available.

• Brand Name: TUBE, SET, STD VOL, UNIV ENDS,
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9483171
• Report Number: 1416980-2019-06953
• Device Sequence Number: 16246062
• Product Code: LHI
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K900585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H93821
• Device Lot Number: 60178034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1