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

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.

• 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 Key: 6093892
• MDR Text Key: 60087387
• Report Number: 2529592-2016-00003
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970187
• Number of Events Reported: 1
• 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 Date: 11/30/2018
• Device Catalogue Number: GIS-28
• Device Lot Number: VL503652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 64