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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

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BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 2C8750
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
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 two (2) clearlink system y-type blood / solution sets were unable to secure the luer lock.This issue was identified during patient set up.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information : the two (2) actual samples were received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed according to specifications.Functional testing was performed including priming the sets with no issues noted.No defects or damaged was observed and the luer lock was tested with no issues noted.The reported condition was not verified on both samples.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 Name
CLEARLINK BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina san cristobal
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina san cristobal
DR  
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8935908
MDR Text Key155700632
Report Number1416980-2019-04658
Device Sequence Number1
Product Code BRZ
UDI-Device Identifier00085412046341
UDI-Public(01)00085412046341
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993120
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 09/25/2019
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 Number2C8750
Device Lot NumberDR19D09051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received09/02/2019
Supplement Dates FDA Received09/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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