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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE INTERLINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SINGAPORE INTERLINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number A2C6606
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received for evaluation. A visual inspection was performed and the collapsed septum was identified; the side of the septum was pushed down. The dimensions of the device were measured and found to be within specifications. Functional testing was performed with no issues noted. The reported condition was verified. The cause of the reported condition could not be determined. 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.
 
Event Description
It was reported the septum of an interlink extension set was collapsed during insertion of a plastic cannula for intravenous (iv) infusion which resulted in a leak. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameINTERLINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
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 Key7070568
MDR Text Key93331286
Report Number1416980-2017-09437
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Catalogue NumberA2C6606
Device Lot NumberSR17B03065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
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

Patient Treatment Data
Date Received: 11/30/2017 Patient Sequence Number: 1
Treatment
.2017
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