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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PCA ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET
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PCA ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 30873
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that pca asv microbore cv had a hole in the tubing.The following information was provided by the initial reporter: it was reported by the medical professional, there was a hole in the tubing.
 
Event Description
It was reported that pca asv microbore cv had a hole in the tubing.The following information was provided by the initial reporter: it was reported by the medical professional, there was a hole in the tubing.
 
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of damage component leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 30873 lot number 19016360 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29jan2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
PCA ASV MICROBORE CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12328582
MDR Text Key266945110
Report Number9616066-2021-51786
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403273940
UDI-Public10885403273940
Combination Product (y/n)N
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/29/2022
Device Catalogue Number30873
Device Lot Number19016360
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2019
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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