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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problems Fluid Leak (1250); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that an unspecified quantity of one-link needle-free iv connectors had connection issues with syringes resulting in radioactive isotope leakage; the connections were not stable. This was identified during unspecified process steps. The threads of the devices did not match up with a firm connection. Decontamination and replacement of the isotope was performed to continue treatments. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The events occurred on unspecified dates, including "last week". The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameONE-LINK NEUTRAL LUER ACTIVATED DEVICE
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 
2242702068
MDR Report Key12913492
MDR Text Key282783063
Report Number1416980-2021-07077
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7N8399
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2021 Patient Sequence Number: 1
Treatment
RADIOACTIVE ISOTOPE FLUID; SYRINGES
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