• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N3326
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
The patient's age was reported as a neonate.Weight: (b)(6) grams.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during use with an interlink t-connector extension set, a disconnection occurred ¿from the hub of the iv catheter¿ which resulted in blood leak.The cause of the disconnection was not reported.It was reported an approximate blood loss of ¿five to six ml¿ occurred.It was reported a transfusion was needed (no further details provided).At the time of this report, the patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
Additional information: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection of the companion sample did not identify any abnormalities that could have contributed to the reported condition.Functional, pressure and clear passage testing were performed and passed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information: a3, b5, b7, e4, g3, h10.B5: upon follow up it was reported blood was observed on the arm board and sheets.The nurse unwrapped the dressing to find that t-connector was dislodged from catheter.It was reported the nurse reconnected and redressed the left radial peripheral ¿a-line¿.It was reported the arterial line was taped and the t-connector was taped securely.It was reported approximately 5ml of blood was lost and packed red cells were given.F2 - the customer reported this event to the fda through medwatch 1000060000-2020-8016.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTERLINK SYSTEM T-CONNECTOR EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9457173
MDR Text Key170425567
Report Number1416980-2019-06849
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412004648
UDI-Public(01)00085412004648
Combination Product (y/n)N
PMA/PMN Number
K060074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2024
Device Catalogue Number2N3326
Device Lot NumberUR19F10039
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received01/07/2020
05/01/2020
Supplement Dates FDA Received01/10/2020
05/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-