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

Catalog Number	H938751
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing detached from the hard plastic spike of a micro-volume inlet.This was found in the cabinet of the cleanroom.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H4: the lot was manufactured from march 29, 2022 ¿ march 30, 2022.H10: the device was received for evaluation.Unaided eye visual inspection was performed under normal room conditions which observed that the inlet spike was detached from the inlet tubing.There was no other damage observed of the vented inlet.Functional testing was not possible due to the condition of the sample.The reported condition was verified.The cause of the condition was due to inadequate solvent being applied to the outer diameter of tube when it was inserted into the spike during 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
• 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: 16418106
• Report Number: 1416980-2023-00618
• Device Sequence Number: 3364899
• 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): 03/24/2023

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: 02/28/2025
• Device Catalogue Number: H938751
• Device Lot Number: 60357823
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown