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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8612
Device Problem Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/22/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified quantity (at least five) of clearlink system extension sets were difficult to unscrew from a non-baxter intravenous (iv) port.The reporter stated that in order to unscrew a kelly clamp was used.This issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Device manufacturer address 1: (b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
D9: device avail.For eval? ¿yes¿, replaced with ¿no¿.D9: date returned to mfr: ¿07/07/2022¿, replaced with ¿na¿ h3: device returned for evaluation? ¿yes¿, replaced with blank.H10: the actual devices were not available; however, a photograph of a companion sample was provided for evaluation.The reported condition was not possible to be observed through the returned picture.The actual device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK LUER ACTIVATED VALVE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS   30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14986499
MDR Text Key296896831
Report Number1416980-2022-03587
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/11/2022
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 Health Professional
Device Catalogue Number2C8612
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/14/2022
Initial Date FDA Received07/12/2022
Supplement Dates Manufacturer Received08/09/2022
Supplement Dates FDA Received08/11/2022
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 Number1
Treatment
KELLY CLAMP; NON-BAXTER SET
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