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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number FNC2110
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported two interlink system solution sets appeared to have "loose pieces in packaging". This issue was identified during setup. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
Additional information was added: two (2) devices were received for evaluation. A visual inspection was performed, and it was noted that one of the returned samples was a complete set with no abnormalities observed. The second returned sample was an incomplete set with the tubing cut approximately 50 cm away from the drip chamber. During the investigation it was established that the second returned sample was cut at a cross-cutter station during the assembly process. The tubing was dislodged from the blister pocket and cut at the cross-cutter station during assembly. The reported condition was not verified for sample one; however, was verified for the second returned sample. The cause of the reported condition was a manufacturing issue. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameINTERLINK SYSTEM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
singapore 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9653649
MDR Text Key177357840
Report Number1416980-2020-00310
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFNC2110
Device Lot NumberSR19G07085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
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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