MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPIKE, UNIVERSAL, LL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	H93829
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a luer lock universal spike was leaking.This issue was further described as, ¿the vent came all the way out, causing fluid to leak from the attached bag¿.The issue occurred before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to d1: brand name: spike, universal, ll, ster (previously submitted as luer lock universal spike).Correction made to d4: expiration date: 03/31/2026 (previously submitted as ni).Correction made to g1: device manufacturer name: availmed (previously submitted as ecm - availmed s.A.De c.V.- sp021332).Additional information was added to g1: device manufacturer e-mail, h4, h6 and h10.H4: the lot was manufactured from april 05,2023 to april 06,2023.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPIKE, UNIVERSAL, LL, STER
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• 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: 17186239
• Report Number: 1416980-2023-03104
• Device Sequence Number: 6391665
• Product Code: NEP
• UDI-Device Identifier: 00085412476544
• UDI-Public: (01)00085412476544
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 03/31/2026
• Device Catalogue Number: H93829
• Device Lot Number: 60452052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown