MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NON VENTED HIGH VOL.INLET,N/S; SET, I.V. FLUID TRANSFER

Catalog Number H938173

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a non-vented high-volume inlet separated from the bag and caused product to spill on the pec surface.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: d1, d4.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that there was liquid in the tubing and the tubing was separated from the spike.The reported condition was verified.The cause of the reported condition could not be determined.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: NON VENTED HIGH VOL.INLET,N/S
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLASTICOS Y MATERIAS PRIMAS PYMPSA; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18476322
• MDR Text Key: 332894377
• Report Number: 1416980-2023-07008
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475783
• UDI-Public: (01)00085412475783
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024

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
• Device Operator: Other
• Device Catalogue Number: H938173
• Device Lot Number: 803579
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/09/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1