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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.
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INTRAVIA CONTAINER EMPTY; CONTAINER, I.V. Back to Search Results
Catalog Number 2B8011
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that plastic pieces broke off into a 150ml intravia container.This was observed when spiking the bag with the tubing spike prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed using the naked eye against white and black background and no particles were observed inside the fluid patjway.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.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INTRAVIA CONTAINER EMPTY
Type of Device
CONTAINER, I.V.
MDR Report Key12418188
MDR Text Key269666068
Report Number1416980-2021-05422
Device Sequence Number1
Product Code KPE
UDI-Device Identifier00085412003467
UDI-Public(01)00085412003467
Combination Product (y/n)Y
PMA/PMN Number
K964853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2B8011
Device Lot NumberDR20K04063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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