MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JP PERF DRN SIL FLT 7MM FULL; CATHETER, IRRIGATION

Model Number	SU130-1310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
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.A review of non-conformant data since (b)(6) 2022 to present was reviewed and no issues that could be related to the condition reported were found.The lot number reported was manufactured on (b)(6) 2021.This is the first incident reported for this lot due to broke.Since the complaint sample was not returned for evaluation, the root cause could not be identified with the information available.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.
Event or Problem Description
Two jp drains were removed.One was removed intact, but the second jp drain broke, and a piece was retained.There were no additional details or contact information received on medwatch mw5116310.

• Brand Name: JP PERF DRN SIL FLT 7MM FULL
• Common Device Name: CATHETER, IRRIGATION
• 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 ; 8478874151
• MDR Report Key: 16865223
• Report Number: 1423537-2023-00930
• Device Sequence Number: 5460909
• Product Code: GBX
• UDI-Device Identifier: 10192253022360
• UDI-Public: 10192253022360
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: SU130-1310
• Device Catalogue Number: SU130-1310
• Device Lot Number: 1211291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/03/2023
• Date Device Manufactured: 09/14/2021
• 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 Sex: Unknown