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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO INTERLINK SYSTEM T-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - AIBONITO INTERLINK SYSTEM T-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N3326
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This event occurred on an unspecified date in (b)(6) 2018. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the packaging was damaged and the tubing of an interlink system t-connector extension set was cut and sticking out of the packaging through the side seal. This was noted prior to use. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the photograph revealed that a part of the set was trapped in the seal area. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. A batch review was conducted and it was found that during manufacturing, blisters with sets cut or trapped in the seal area of the blister during the packaging process were identified and discarded. Awareness training was provided to involved personnel. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameINTERLINK SYSTEM T-CONNECTOR EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - AIBONITO
aibonito
Manufacturer (Section G)
BAXTER HEALTHCARE - AIBONITO
rd 721 km 0 3 po box 1389
aibonito 00705
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7969344
MDR Text Key124356061
Report Number1416980-2018-06565
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2N3326
Device Lot NumberUR18F17068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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