MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JPH 19FR RND FULL W/15FR TRO; CATHETER, IRRIGATION

Model Number	JP-HUR910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 or Problem Description
Customer reported that drain insertion was performed for post breast surgery patient with a diagnosis of malignant tumor of the breast part, unspecified.Patient was discharged with 2 round silicone drains in the surgery site for drainage.On september 28 that the drain broke in the distal portion near the end of the drain and the pump.Drain piece was replaced.No injury or further surgery was reported.No further information was provided upon request.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report that was submitted on 11/21/2021 due to the investigation findings are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.A sample was not received for investigation.Root cause for the reported concern cannot be identified with the information provided.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.As preventive actions, the customer will be provided with a copy of the instructions for use.No further action is planned at this time.

• Brand Name: JPH 19FR RND FULL W/15FR TRO
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• 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: 15839722
• Report Number: 1423537-2022-00862
• Device Sequence Number: 6996183
• Product Code: GBX
• UDI-Device Identifier: 00192253022219
• UDI-Public: 192253022219
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: Lay User/Patient
• Device Model Number: JP-HUR910
• Device Catalogue Number: JP-HUR910
• Device Lot Number: 1201029
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female