MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO HEMADUCT, 10FR 3/4 DUCTED; CATHETER, IRRIGATION

Model Number	JP-HUR100
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sample was not available for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.The device history record (dhr) for the finished good was reviewed and no incident was documented that could have caused this type of non-conformance.No reported non-conformances were found from review of the records.The minimum pull test specification for this drain is 3.0 lbs.Dhr demonstrated pull test results of a minimum of 5.1 lbs.The non-conformance report (ncr) data since july 2017 to present was reviewed and no issues that could be related to the catalog number and condition reported were found.An analysis of the complaint data was also reviewed for the same time period and demonstrates that this is the first time that this type of issue is reported from this catalog number in the last 12 months.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.(b)(4).Med watch5077883.Pdf.
Event or Problem Description
The drain was placed post-operatively due to a large empty space after the goiter resection.The patient did well after surgery, and came back today to have her drain removed at the clinic.The drain broke at the skin, and she was taken to the operating room where they removed the drain (under local anesthesia with iv sedation) without difficulty.She did well - they only had to remove 2 sutures, replace them, and she was sent home.The drain was discarded.

• Brand Name: HEMADUCT, 10FR 3/4 DUCTED
• 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: 7724217
• Report Number: 1423537-2018-00227
• Device Sequence Number: 1588701
• Product Code: GBX
• UDI-Device Identifier: 10630140032639
• UDI-Public: 10630140032639
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: JP-HUR100
• Device Catalogue Number: JP-HUR100
• Device Lot Number: 1131377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO