MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number	IPN033360
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "the patient presents a medication leakage at the insertion site of the picc catheter.Upon removal, the exit of fluid is verified and observed at the junction between the catheter and the blue securing part.Subsequently, a saline solution test is performed using a syringe, confirming that the liquid leakage is due to a breakage in that area.It is important to note that the catheter had been inserted approximately 24 hours ago." it was reported a crack was observed.The catheter was removed and a peripheral line was placed.There was no harm to the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "the patient presents a medication leakage at the insertion site of the picc catheter.Upon removal, the exit of fluid is verified and observed at the junction between the catheter and the blue securing part.Subsequently, a saline solution test is performed using a syringe, confirming that the liquid leakage is due to a breakage in that area.It is important to note that the catheter had been inserted approximately 24 hours ago." it was reported a crack was observed.The catheter was removed and a peripheral line was placed.There was no harm to the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A device history record review was performed based on sales history, 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.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17323707
• Report Number: 9680794-2023-00519
• Device Sequence Number: 17553084
• Product Code: LJS
• UDI-Device Identifier: 10801902095371
• UDI-Public: 10801902095371
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: Health Professional
• Device Model Number: IPN033360
• Device Catalogue Number: PR-05052
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PROPOFOL AND FENTANYL INFUSION; PROPOFOL AND FENTANYL INFUSION
• Patient Age: 44 YR
• Patient Sex: Unknown