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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number ASKU
Device Problems Clamp (757); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter address: (b)(6). Manufacturing facility: this device was manufactured at one of the two following manufacturing sites: (b)(4). The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the clear clamps of an unspecified quantity of unspecified eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were difficult to close. This issue was identified during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameNI
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
see h10
see h10
see h10
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10549116
MDR Text Key207421679
Report Number1416980-2020-05775
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 09/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Is this a Reprocessed and Reused Single-Use Device? No

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