MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JP PERF DRN SIL FLT 10MM FULL; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-1311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently under investigation.A follow up report will be filed once the results have been completed.
Event or Problem Description
Med watch report number 1002890000-2024-8006: the patient underwent a liver transplant.During the follow up office visit over 3 weeks later, the physician attempted to remove the jackson-pratt (jp) drain, but it broke off.The patient was taken to the operating room for removal of the remaining part.Patient was given general anesthesia.The piece was removed by opening of the skin and subcutaneous and extending all oblique fascia, retrieval of the remnant of the jp drain, closure of the external fascia and skin.
Additional Manufacturer Narrative
The customer sample was not available for evaluation.Since the complaint sample was not returned for evaluation, the root cause could not be identified with the information available.It is vital to the investigation that the customer sample be available for examination and testing.The device history records (dhr) for the finished good was reviewed and no incident was documented that could have caused this type of issue.This is the first incident reported for this lot due to broken parts.An analysis of the complaint data ((b)(6) 2023 ¿ (b)(6) 2024) demonstrates that this is the first time that this type of issue is reported from this catalog.As preventive action, customer will be provided with a copy of the directions for use and the condition will continue to be monitored.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: JP PERF DRN SIL FLT 10MM FULL
• 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
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19831004
• Report Number: 1423537-2024-00087
• Device Sequence Number: 8102867
• Product Code: GCY
• UDI-Device Identifier: 10192253022377
• UDI-Public: 10192253022377
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SU130-1311
• Device Catalogue Number: SU130-1311
• Device Lot Number: 1230584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 05/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 62 KG