MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JACKSON PRATT 10MM FLAT DRAIN FULL PERF; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number SU130-1311

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  malfunction  

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.As no lot number was provided, we were unable to trace the device history record, quality testing performed, and corresponding results.The none conformance report data since march 2019 to present was reviewed and no issues that could be related to the catalog number 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.- [medwatch report mw5093398 (b)(4)].

Event Description

Medwatch report mw5093398 received stating (b)(6) underwent partial nephrectomy.A jackson pratt drain was placed at the time on (b)(6).During bedside jp drain removal on (b)(6), drain fractured and a piece was retained.Patient required additional procedure to remove retained piece.

• Brand Name: JACKSON PRATT 10MM FLAT DRAIN FULL PERF
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• 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 ; 8478874152
• MDR Report Key: 9955663
• MDR Text Key: 187974833
• Report Number: 1423537-2020-00451
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 10885380064036
• UDI-Public: 10885380064036
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2020

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
• Device Operator: Health Professional
• Device Model Number: SU130-1311
• Device Catalogue Number: SU130-1311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR