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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8301
Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received and is currently awaiting evaluation completion. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the sterile packaging of one-link non-dehp standard bore catheter extension set was tearing and would not open correctly. This was identified prior to use. There was no patient involvement. No additional information is available.
 
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Brand NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key11216752
MDR Text Key230063584
Report Number1416980-2020-08589
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8301
Device Lot NumberUR18A20469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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