MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JP 19FR SILICONE DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-1325
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sample was not returned for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.If the sample becomes available, it can be forwarded to us so further evaluation can be performed.The non-conformance report (ncr) data from (b)(6) 2018 to present was reviewed and no issue that could be related to the condition reported was found.The device history record (dhr) for the finished product was reviewed and no incident was documented that could have caused this type of non-conformance.This is the first incident reported for this lot number due to any type of complaint.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 (broken drain) is reported for this catalog number in the last 12 months.The lot number reported was manufactured on october 18, 2018.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, ¿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.
Event or Problem Description
Customer reported drain removed on (b)(6) 2019 at patient bedside by physician and fragment remained in patient.Fragment successfully removed during surgery on (b)(6) 2019.Patient was released from hospital to long term acute care on (b)(6) 2019.

• Brand Name: JP 19FR SILICONE DRAIN
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 8803661
• Report Number: 1423537-2019-00333
• Device Sequence Number: 10877110
• Product Code: GCY
• UDI-Device Identifier: 10885380064074
• UDI-Public: 10885380064074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: SU130-1325
• Device Catalogue Number: SU130-1325
• Device Lot Number: 1181198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR