MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPIKE, UNIVERSAL, LL, STER; SET, I.V. FLUID TRANSFER

Catalog Number H93829

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an unspecified quantity of luer lock universal spike was contaminated.It was further specified that the packaging was wet.This issues was identified during setup and preparation there was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction to the previously submitted d4:lot #, expiration date and unique identifier (udi) #.D4: lot #: 60229365 previously submitted 60232935.D4: expiration date: 01/31/2023 previously submitted 02/28/2023.D4: unique identifier (udi) #: (b)(4) previously submitted (b)(4).H10: three (3) actual samples were received for evaluation.Unaided visual inspection was performed which observed contaminated dark/transparent areas of the primary packaging on the back side and seen through on the front side of all samples.The cause of the condition was not determined.Functional testing was not performed for this complaint.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: SPIKE, UNIVERSAL, LL, STER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10179570
• MDR Text Key: 195955841
• Report Number: 1416980-2020-03489
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: H93829
• Device Lot Number: 60229365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.