MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the picc was functioning well for 20 days at home.On monday 10/9, at approximately 12pm, the home care nurse changed the dressing and drew labs from the picc.The patient's wife reported that she had a hard time flushing the picc at 5:30pm and was unable to administer his 5:30pm meds.Home care came back out on 10/10 and said the picc was leaking and had a pinhole in it.On assessment in the ed today at 2pm, the picc was completely occluded and there was leaking through a pinhole at the 2.5cm mark of picc catheter.Vat nurse removed the picc, and vat placed the picc in a biohazard bag and forcefully flushed the picc.A large clot came out of the picc and visible small leak at the 2.5cm mark of catheter.A new line was inserted in the opposite arm.There was no reported patient harm or consequence.They were reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the picc was functioning well for 20 days at home.On monday 10/9, at approximately 12pm, the home care nurse changed the dressing and drew labs from the picc.The patient's wife reported that she had a hard time flushing the picc at 5:30pm and was unable to administer his 5:30pm meds.Home care came back out on 10/10 and said the picc was leaking and had a pinhole in it.On assessment in the ed today at 2pm, the picc was completely occluded and there was leaking through a pinhole at the 2.5cm mark of picc catheter.Vat nurse removed the picc, and vat placed the picc in a biohazard bag and forcefully flushed the picc.A large clot came out of the picc and visible small leak at the 2.5cm mark of catheter.A new line was inserted in the opposite arm.There was no reported patient harm or consequence.They were reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 1-lumen picc catheter for analysis.Signs of use in the form of biological material were observed on the catheter.Visual analysis revealed a hole in the picc catheter body between the 2cm and 3cm marking.The distal end of the catheter was severed and it is assumed the catheter was intentionally severed.Microscopic examination revealed that the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Needle bevel, scissors , scalpel, etc).The hole in the catheter body measured 3.8mm from the juncture hub.The catheter body length from the juncture hub to the severed end measured 48cm, which is not within the specification limits of 58.56-63.64 cm per the catheter product drawing , therefore, at least 10.56cm of the catheter body was severed and not returned.The catheter body outer diameter measured 0.06030" , which is within the specification limits of 0.0580"-0.0610" per the catheter extrusion product drawing.A lab inventory syringe filled with water was attached to the extension line and flushed.When flushing the extension line, water was observed leaking out of the hole in the catheter body.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The ifu also informs users how to trim the catheter, "cut catheter straight across (90 to catheter cross-section) using trimming device (where provided) to maintain a blunt tip." the report of a leaking catheter body was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed a hole 3.8mm from the juncture hub on the catheter body extrusion.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Needle bevel, scissors, scalpel, etc).Based on the customer report and the sample received, unintentional use error (contact with sharps) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 18072274
• Report Number: 9680794-2023-00828
• Device Sequence Number: 7815120
• Product Code: LJS
• UDI-Device Identifier: 10801902208696
• UDI-Public: 10801902208696
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: DLX-45541-CURVB
• Device Lot Number: 13F22L0946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Male