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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8370K
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The date of the event was reported as an unknown date in (b)(6) 2021.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported an unspecified quantity of one-link non-dehp y-type microbore catheter extension set s disconnected.It was further reported, there were "multiple disconnections" from non-baxter tubing.The event occurred during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was 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 Name
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12464610
MDR Text Key271301146
Report Number1416980-2021-05638
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7N8370K
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
BD TUBING
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