MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO KIT DRAIN 100CC W/7MM PERF; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number SU130-1360

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

This complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow up report will be filed once the results have been completed.

Event Description

Per customer, health care professional was asked to assist with removing a jackson pratt drain from patient's lower abdomen.It was confirmed that drain to the right of her lower abdomen horizontal incision had the suture securing the drain removed already.Health care professional explained the procedure to the patient and began pulling on the jp drain with the usual amount of force.Jp drain was not coming out easily.Moderate resistance felt.Health care professional repositioned hand on drain closer to insertion site and began to pull with moderate force when drain broke and retracted back into insertion site.Health care professional did not use excessive force and has successfully removed jp drains with the same amount of moderate force on other patients before.Health care professional was very surprised that drain broke with that amount of force.Either drain tubing is reportedly defective and broke with moderate force or perhaps the drain was sutured inside the abdomen accidently during prior emergency surgery and was compromised by a suture.Patient to go back for surgery to open the lower abdominal wound to retrieve the remaining piece of drain from the patient's abdomen.Health care professional stated all broken pieces of drain/tubing were retrieved and patient discharged with no additional issues.No patient demographics or other information provided.

Manufacturer Narrative

Lot number 1200875 was entered in d4 on the initial report in error.Customer was unable to confirm lot number and the packaging was not kept.Since no lot number was provided, we were unable to trace the device history record, quality testing performed and corresponding results.The nonconformance data since april 2021 to present was reviewed and no issues that could be related to the catalog number and condition reported were found.The actual customer sample was received for investigation inside of plastic bag, not its original package.Our visual examination of the returned product revealed it is a kit drain 100cc w/7mm perf as reported.Visual inspection of the returned product revealed that the clear silicone tubing broke.The microscopic examination revealed a wavy/jagged edge at the tubing fracture site.No indications of stretched tube were observed.The characteristic of the fractured area suggests that an instrument was used to handle the product.Per instructions for use, if the drain is implanted for a period that allows tissue ingrowth around the drain this can cause the drain to break during removal.In addition, instructions for use indicate that drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.Also, 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).The most probable root cause was identified as misuse by the customer since the wavy/jagged edge condition observed at the fracture area suggests that an instrument was used to handle the product.Use of an instrument to handle the product may have inadvertently damage the product thus leading to tubing breakage.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.¿ cardinal health will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: KIT DRAIN 100CC W/7MM 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14316003
• MDR Text Key: 291204759
• Report Number: 1423537-2022-00763
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 10192253022537
• UDI-Public: 10192253022537
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SU130-1360
• Device Catalogue Number: SU130-1360
• Device Lot Number: 1200875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1