MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO 100CC KIT W/10MM FULLY PERFORATED DRAIN; CATHETER, IRRIGATION

Model Number	SU130-1371
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample was not available for evaluation.It is vital to the investigation that the complaint sample be available for examination and testing.If the sample becomes available at a later date, it can be forwarded to us so further evaluation can be performed.As no lot number was provided, we were unable to trace the device history record (dhr), quality testing performed and corresponding results.The non-conformance report (ncr) data since november 2017 to present was reviewed and no issues that could be related to the catalog number and conditions reported were found.Root cause for the reported concern cannot be identified with the amount of information available.It was concluded from samples evaluated from incidents investigated in other product codes for the same condition that this type of failure is commonly caused by product mishandling during surgical procedure.As preventive actions, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.According to the instructions for use (ifu).¿drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.To facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).Drains should be placed and removed carefully by hand only with a slow, steady pressure.Excessive force may result in breakage.During placement and removal of the drain, do not nick, cut, tear or otherwise damage the drain as this may lead to breakage.Leaving the drain implanted for any period of time which allows for tissue in-growth around the drain and into the holes, may cause breakage on removal.¿ we will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
Hemovac tube failure.There was some resistance during removal at 24 hours post op and it broke.Not atypical.Patient was returned to surgery due to broken piece of tubing found behind patella.

• Brand Name: 100CC KIT W/10MM FULLY PERFORATED DRAIN
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 8229202
• Report Number: 1423537-2019-00250
• Device Sequence Number: 19070194
• Product Code: GBX
• UDI-Device Identifier: 10885380039904
• UDI-Public: 10885380039904
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SU130-1371
• Device Catalogue Number: SU130-1371
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1