MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: there was difficulties flushing the picc line.Additional information: access was in the basilic vein.There was no visible damage to the catheter reported.They removed the entire catheter and replaced with another device.There was a delay to treatment but no other harm or consequence to the patient.
Event or Problem Description
It was reported that: there was difficulties flushing the picc line.Additional information: access was in the basilic vein.There was no visible damage to the catheter reported.They removed the entire catheter and replaced with another device.There was a delay to treatment but no other harm or consequence to the patient.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
Qn # (b)(4).The customer returned one, opened picc kit including: two straight guide wires within their advancers (one 45 cm and one 80 cm), a 21ga introducer needle, a 10ml syringe, a single-lumen picc catheter, and the product lidstock for analysis.No obvious signs of use were observed on the catheter body.Visual inspection of the picc catheter revealed no obvious defects or anomalies.The length of the catheter body from the juncture hub to the distal tip measured 19 13/16" which is within the specifications of 19 1/2" - 20" per catheter product drawing.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal lumen was flushed using the returned 10ml syringe.The extension line and catheter body flushed as intended.No leaks or blockages were observed.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit warns the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter.Minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Visual inspection of the picc catheter revealed no obvious defects or anomalies.The returned catheter met all relevant dimensional/functional requirements, and was able to flush as expected with no blockages observed.A device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: there was difficulties flushing the picc line.Additional information: access was in the basilic vein.There was no visible damage to the catheter reported.They removed the entire catheter and replaced with another device.There was a delay to treatment but no other harm or consequence to the patient.

• Brand Name: ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG
• 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: 17918238
• Report Number: 9680794-2023-00754
• Device Sequence Number: 2957149
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: 00801902101051
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/15/2023

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
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 13F22A0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 04/22/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/06/2023; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown