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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION VENTED MICRO VOL.INLET, N/S SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938175
Device Problems Cap (424); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 03/03/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that there was "oily foreign material" at the cap of a vented micro-volume inlet. This was noted prior to patient use. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

Additional information was added: the device was received for evaluation. A visual inspection was done with the unaided eye under normal room conditions which observed a very thin silicone residue on the surfaces of the spike and inside surfaces of the cap that was most likely applied as part of the manufacturing process. This issue was not considered a defect as medical grade silicone oil is required by these products for proper assembly and functionality and no excess silicone was observed. Therefore, no issues were found with the device related to the customer reported problem. The reported condition of oil foreign material at the cap was not verified. No functional testing was performed on this sample. 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.

 
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Brand NameVENTED MICRO VOL.INLET, N/S
Type of DeviceSET, 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 Key9886322
MDR Text Key185191530
Report Number1416980-2020-01768
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberH938175
Device LOT Number802720
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/26/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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