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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AQUABILITI AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

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AQUABILITI AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 2S0706
Device Problems Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2016
Event Type  malfunction  
Manufacturer Narrative
This retrospective mdr is filed as a correction to an audit conducted 06-jun-2017 by a former (b)(4) investigator (consultant).We observed the syringe was dirty with a surface grease-like substance that was confined to the end of the barrel of the syringe, but no loose particulate matter.Production final inspection includes a visual check of all product.A review of the device history record showed that samples met in process and final inspection acceptance criteria.Sixty (60) retain samples from lot kh04306 were evaluated, and zero defected syringes were observed.We reviewed the historical customer complaint data and cars for the same product code (2s0706) for the year 2015 and did not find any similar dirty syringe complaints.Customer reported 106 syringes, but further investigation by the customer revealed that the true number of rejected syringes was actually three (3).The original reported number was determined to be inadequate training of the customer's personal on specifications.It was determined that the syringe was received from the supplier as dirty.The supplier was notified and no conclusive root cause had been received at the processing time of this complaint.
 
Event Description
During aql inspection, customer reported 106 syringes were found with particulate matter contained within syringe pouches.
 
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Brand Name
AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
AQUABILITI
5209 linbar drive
suite 640
nashville TN 37211
Manufacturer Contact
dave meily
5209 linbar drive
suite 640
nashville, TN 37211
6158332633
MDR Report Key6725899
MDR Text Key80642128
Report Number1057300-2017-00001
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00859809005002
UDI-Public859809005002
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/11/2018
Device Model Number2S0706
Device Catalogue Number2S0706
Device Lot NumberKH04298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/01/2016
Initial Date FDA Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2016
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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