MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PERITONEAL LAVAGE CATH KIT:8FR; CATHETER PERITONEAL

Catalog Number	AK-09001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported "patient complain of pain on site when checked, the tube site leaking and peritoneal catheter was left inside patient , resulting patient for surgery ".Additional information was requested but not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received from the customer on (b)(6) 2024 indicates "pre procedure us and fluoroscopy images showed the catheter cut in to two parts: superficial and deep.One removed via fluoroscopy guided [17/08 at 1324h (superficial/subcutaneous) but (the deep, intra peritoneal) cannot be retrieved.Second one, (the deep or intraperitoneal foreign body) retrieved via laparoscopic exploration [17/08 at 2246h]." it was also reported that "the patient underwent 2 invasive procedures to retrieve the foreign bodies." the patient condition was reported as "stable" after surgery.
Event or Problem Description
Customer reported "patient complain of pain on site when checked, the tube site leaking and peritoneal catheter was left inside patient , resulting patient for surgery ".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported "patient complain of pain on site when checked, the tube site leaking and peritoneal catheter was left inside patient , resulting patient for surgery ".Additional information was requested but not available at the time of this report.

• Brand Name: ARROW PERITONEAL LAVAGE CATH KIT:8FR
• Common Device Name: CATHETER PERITONEAL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17965601
• Report Number: 9680794-2023-00787
• Device Sequence Number: 12441379
• Product Code: GBW
• UDI-Device Identifier: 10801902005240
• UDI-Public: 10801902005240
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K811627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2023

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?: Yes
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: AK-09001
• Device Lot Number: 13F21A0271
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 11/13/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/14/2023; 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown