MAUDE Adverse Event Report: URESIL, LLC ORIGIN DRAINAGE CATHETER

Model Number GPL2-1030H

Device Problem Fracture (1260)

Patient Problem Pneumothorax (2012)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: uresil performed investigative testing on unused product from the same lot and product manufactured the same day.It is possible that this incident was caused by this over-tightening by the user combined with manufactured product that was potentially on the low side in terms of torque.Uresil reviewed the manufacturing records for this lot of product and no related issues were noted.All product released to the field passed 100% testing for luer engagement and leak; it is possible that current testing parameters would not detect this failure mode (cracked luer) adequately, as luer engagement is not currently quantified and no minimum torque specification has been determined for as-manufactured product.There is no evidence of design defect.Uresil's risk management indicates a related potential failure/hazard, which is assigned degree of severity "negligible" and acceptable rate of occurrence "(b)(4) (occasional)": "luer cracks when engaged by user for flushing/attachment of drainage collecting device or other drainage accessory" with potential outcome "might require catheter replacement." to investigate for potential manufacturing related causes of a cracked luer in the field, samples from the affected lot as well as samples created the same day were torque tested to failure.37 samples from the affected lot (all available unused product) were torque tested to destruction.Two out of 37 pcs failed below the torque specification for the as-molded luer (i.E.Prior to gluing).13 samples each were tested from 3 other lots manufactured on the same day; all passed above the torque specification for the as-molded luer.In an attempt to determine the root cause of the field failure, additional luer/hub assemblies were created with the following possible errors: too much glue, possibly leading to uncured glue which may cause cracking; uv emitter power too low, possibly leading to uncured glue which may cause cracking; glue not cured in the uv emitter, left in its uncured state and cured with ambient light.With the first two scenarios, all pieces passed well above the as-molded luer torque specification.With the last scenario, 3 groups of uncured parts were tested: ambient curing for 30 minutes, 1 hour and 2 hours.Assemblies at 30 minutes and 1 hour pulled out immediately.Half of the assemblies tested at two hours pulled out immediately, but half of the assemblies' luers cracked below the as-molded luer torque specification.Root cause analysis: failure mode- cracked luer: use error- overtightening of luer beyond normal use (note: a caution against overtightening of the luer is listed in the ifu); hazard- pneumothorax- cracked luer allowed air into the patient's chest, and hospital personnel did not take timely action to address cracked luer.Corrective actions taken as a result of the investigation: while root cause has been determined to be overtightening of the luer as stated by the end user, uresil has opened an investigation to determine and quantify appropriate torque value for "normal use" and institute routine monitoring of torque values of manufactured product to ensure that manufactured product meets expections for normal torque.No recall/field safety corrective action is required, as risk of pneumothorax is negligible and does not represent a serious public health threat.Uresil has never received a complaint of a drainage catheter causing a pneumothorax in over 25 year history with this device; additionally, this hazard was not identified through clinical evaluation.Uresil will update its risk management to address the risk of pneumothorax.

Event Description

A uresil drainage catheter was placed in the patient as a chest drainage tube on (b)(6) 2019.The next day ((b)(6) 2019), a leak was detected and the catheter was found to be blocked.The catheter was flushed with saline and hub leakage was again noted.Even though the hospital was aware of this leak, the catheter was not replaced until 2 days later - (b)(6) 2019.The hospital also stated that they intentionally "over-tighten" these types of catheter connections, and most likely used a metal instrument to over-tighten the connection.The hospital recognizes that the leaking catheter situation should have been addressed sooner, and it is uresil's understanding that they intend to change their internal procedures regarding timely addressing of noted issues like leaking devices and to not use metal instruments to tighten connections.

• Brand Name: ORIGIN DRAINAGE CATHETER
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• Manufacturer (Section G): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• Manufacturer Contact: courtney wallace ; 5418 w touhy ave; skokie, IL 60077 ; 8479820200
• MDR Report Key: 8981077
• MDR Text Key: 161716994
• Report Number: 1450395-2019-00001
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: H862GPL21030H0
• UDI-Public: H862GPL21030H0
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: GPL2-1030H
• Device Catalogue Number: GPL2-1030H
• Device Lot Number: 9E423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 60