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

Catalog Number H93821

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2019

Event Type  malfunction  

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 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,
• 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: 9483171
• MDR Text Key: 171861940
• Report Number: 1416980-2019-06953
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520
• Combination Product (y/n): N
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1