MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO UNKNOWN PRODUCT-MED; CATHETER, IRRIGATION

Model Number UNKNOWN PRODUCT-MED

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The actual customer sample was not returned for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.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 july 2018 to present was reviewed and no issues that could be related to the catalog and condition reported were found.Root cause for the reported concern cannot be identified with the amount of information available.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 ingrowth 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.- [(mw5088434) (b)(4).

Event Description

During jp drain removal, tube fractured along round portion and half the tube was left inside the abdomen requiring laparoscopy removal of tube.

• Brand Name: UNKNOWN PRODUCT-MED
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9040387
• MDR Text Key: 164252431
• Report Number: 1423537-2019-00345
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 43