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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N1333
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the luer of a non-dehp standard bore catheter extension set broke off. It was further reported that the clamp "cut through" the tubing. It was not specified when in the process this occurred. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameEXTENSION SETS
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 Key10130698
MDR Text Key194393704
Report Number1416980-2020-03190
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2N1333
Device Lot NumberUR20A21034
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 Received07/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2020
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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