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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND ACCESS; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE - CLEVELAND ACCESS; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 1C8687
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(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 an unspecified component of a clearlink system blood bag spike adapter was flimsy.This was not noticed during patient use or during set-up.There was no patient involvement.No additional information is available.
 
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Brand Name
ACCESS
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer (Section G)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5451617
MDR Text Key38710011
Report Number1416980-2016-03870
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2016
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 No Information
Device Catalogue Number1C8687
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/01/2016
Initial Date FDA Received02/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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