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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GI SUPPLY GI SUPPLY LARGE VOLUME PARACENTESIS KIT; PARACENTESIS KIT, PRODUCT CODE: LRO

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GI SUPPLY GI SUPPLY LARGE VOLUME PARACENTESIS KIT; PARACENTESIS KIT, PRODUCT CODE: LRO Back to Search Results
Catalog Number GIS-28
Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 09/30/2016
Event Type  malfunction  
Manufacturer Narrative
The facility that reported the incident used the renova rp paracentesis pump with the single use large volume paracentesis kit on the patient before the incident occurred and had no issues.The description provided is that the tubing began to spray from the connector between the larger diameter tubing section and smaller diameter tubing on the right side of the pump head (exiting the pump head).The nurse was sprayed with fluid.The pump was turned off and tubing was removed.A new kit was opened and the procedure was resumed without incident.A picture of the kit in the pump was sent to the nurse to identify exactly where the tubing came apart.The large volume paracentesis kit with the issue of the tubing coming apart was discarded by the nurse.The description of the issue along with the pictures has been sent to the contract manufacturer for investigation.An interim notice from the contract manufacturer has been received where immediate actions were taken to test the affected lot number retains for tubing joint pull test, to pull random samples & perform tubing joint pull test on remaining inventory of affected lot number and to perform dhr review on affected lot number.No product test failures or discrepancies were found.Gi supply performed a qa/qc review of the testing performed at incoming inspection.The testing includes verifying the integrity of the tubing set and a leak test while the kit is connected to the pump.All testing met specifications.Additional testing on five retains was performed by testing the tubing as similar fluid was run through the pump.All testing was designed and performed based on the complaint issue described.No instances of leakage or separation were observed during the testing.This appears to be an isolated manufacturing incident.Corrective action has been requested to the contract manufacturer.Device not returned.
 
Event Description
A customer complaint was received on 30 september 2016.The issue occurred when the user, a nurse, was performing the paracentesis fluid removal on a patient using the large volume paracentesis kit in conjunction with the renovarp paracentesis pump.During the procedure, the tubing began to spray from the connector between the larger diameter tubing section and the smaller diameter tubing on the right side of the pump head (exiting the pump head).This resulted in the user being exposed to the patient's body fluid.The user confirmed there was no injury but since the user indicated that she was exposed to the fluid, the incident is being reported due to the exposure to the patient's body fluid.
 
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Brand Name
GI SUPPLY LARGE VOLUME PARACENTESIS KIT
Type of Device
PARACENTESIS KIT, PRODUCT CODE: LRO
Manufacturer (Section D)
GI SUPPLY
200 grandview avenue
camp hill PA 17011
Manufacturer (Section G)
GI SUPPLY
200 grandview ave
camp hill PA 17011
Manufacturer Contact
gloria ferko
200 grandview ave
camp hill, PA 17011
8004515797
MDR Report Key6093892
MDR Text Key60087387
Report Number2529592-2016-00003
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/27/2016
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 Nurse
Device Expiration Date11/30/2018
Device Catalogue NumberGIS-28
Device Lot NumberVL503652
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/30/2016
Initial Date FDA Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 YR
Patient Weight64
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