MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INLET, MICROVOL, VENTED SPIKE; SET, I.V. FLUID TRANSFER SET

Catalog Number	H938751
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a disconnection between the tubing and spike of a micro-volume inlet (w/large bore spike) which resulted in a leak.The issue was identified during compounding.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: device manufactured on october 14, 2022- october 18, 2022.H10: the device was received for evaluation.Unaided eye visual inspection was performed and the inlet spike was observed detached from the inlet tubing.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition could not be determined, however the most likely cause was due to inadequate or lack of solvent being applied to the outer diameter of the tube when it was inserted to the spike in the manufacturing process.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: INLET, MICROVOL, VENTED SPIKE
• Common Device Name: SET, I.V. FLUID TRANSFER SET
• 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: 16230158
• Report Number: 1416980-2023-00110
• Device Sequence Number: 14770611
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K903159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 09/30/2024
• Device Catalogue Number: H938751
• Device Lot Number: 60325014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown