MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO HEMADUCT 19FR 3/4 DUCTED; CATHETER, IRRIGATION

Model Number	JP-HUR190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
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 was placed in the operating room.When the drain was removed in the unit, the end piece of the drain broke off in the patient and stayed in the patient.Patient had to return to surgery today to remove the piece of drain.No further information was provided.
Additional Manufacturer Narrative
No samples were returned by the customer for evaluation; therefore, we are unable to confirm the root cause for the issue reported.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.A review of nonconformance data since june 28, 2022 to present was reviewed and no issues that could be related to the condition reported were found.This is the first incident reported for this lot number for the reported failure.Although no sample was received, instructions for use evaluation was performed to confirm that the required steps to avoid breakage of the drain are available.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: HEMADUCT 19FR 3/4 DUCTED
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17367801
• Report Number: 1423537-2023-00964
• Device Sequence Number: 15005396
• Product Code: GBX
• UDI-Device Identifier: 10192253022148
• UDI-Public: 10192253022148
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: JP-HUR190
• Device Catalogue Number: JP-HUR190
• Device Lot Number: 1221763
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 07/21/2023
• Date Device Manufactured: 01/17/2023
• 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 Sex: Unknown