MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-L 16 GA X 27-1/2 IN (70 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PS-01672
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the procedure of passing a peripheral insertion central catheter - picc.To the patient is performed, when performing the procedure, they observe that there is no blood return, they evaluate the catheter positioning, without finding any eventuality, when no return is obtained, they remove it and try with another catheter with which they obtain immediate return, the extracted catheter is tested for permeability, finding an unusual resistance, it is necessary to make much force to the embolus and the amount that passes is minimal.This event implied the double puncture of the patient.The patient was reported as fine post the procedure with no harm reported." associated complaints 9680794-2024-01203 and 9680794-2024-01200.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shoes a two-lumen picc within its packaging.The complaint of catheter blocked was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." it also states, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Flush lumen(s) to completely clear blood from catheter." without the device to evaluate, 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
It was reported that: "the procedure of passing a peripheral insertion central catheter - picc to the patient is performed, when performing the procedure, they observe that there is no blood return, they evaluate the catheter positioning, without finding any eventuality, when no return is obtained, they remove it and try with another catheter with which they obtain immediate return, the extracted catheter is tested for permeability, finding an unusual resistance, it is necessary to make much force to the embolus and the amount that passes is minimal.This event implied the double puncture of the patient.The patient was reported as fine post the procedure with no harm reported." associated complaints 9680794-2024-01205, 9680794-2024-01203 and 9680794-2024-01200.

• Brand Name: ARROW PICC SET: 2-L 16 GA X 27-1/2 IN (70 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20853481
• Report Number: 9680794-2024-01205
• Device Sequence Number: 3838720
• Product Code: LJS
• UDI-Device Identifier: 00801902095848
• UDI-Public: (01)00801902095848(11)240617(17)250831(10)14F24F0066(21)
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: PS-01672
• Device Lot Number: 14F24F0066
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2024
• 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
• Patient Sex: Male