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

Catalog Number H938175

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that eight (8) vented micro-volume inlets leaked through the filter/vent.This was identified after inverting the bottles (ascorbic acid) during preparation; further observed right after spiking or halfway through a session.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: eight (8) devices and photographs of the samples were received for evaluation.Visual inspection of the actual devices did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with the em2400 exactamix main module and a leak was not observed of the 8 samples.System level testing was performed in which the samples were properly spiked to a small volume 10 ml vial and no leak was observed at the vent filter section of the samples.The reported condition was not verified of the actual samples.Photographs were also available of the reported leakage that occurred most likely from using the product inappropriately with a 50 ml vial when it is intended for use with a small vial only.The possible cause for the leak was due to use/user error.The exactamix compounder operator manual instructs users the inlets are to be used with small volume vials with a standard priming volume of 5¿6 ml.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: VENTED MICRO 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: 16445203
• MDR Text Key: 310335092
• Report Number: 1416980-2023-00688
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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
• Device Operator: Other
• Device Catalogue Number: H938175
• Device Lot Number: 803391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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