MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 4 FR X 50 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN919406

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: picc inserted (b)(6)2023.Blood was found to be leaking from the line when flushed, during use on patient.When investigated the line was found to be fractured on the external section immediately proximal to the junction hub.The line has been removed.Additional information: there is no evidence from the device of it being pulled or stretched.No evidence of air entering vasculature.Alternate iv access was obtained and iv therapy continued.No additional intervention was required and no reported patient harm.The patient was fine post issue.

Manufacturer Narrative

(b)(4) the customer report of an extension line leak was confirmed through investigation of the returned sample.The customer returned one s-l picc catheter for analysis.Definite signs of use in the form of biomaterial were found on the catheter body.Initial visual analysis of the catheter revealed no obvious defects or anomalies.After failing functional testing, a hole was observed on the extension line adjacent to the juncture hub.The edges of the hole were smooth and uniform.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E., scissors, scalpel, etc.).No other defects or anomalies were observed on the catheter.The overall length of the catheter measured 20" via calibrated ruler which was within the specification limits of 19.812" - 20" per the catheter product drawing.The outer diameter (od) of the catheter measured 0.0545" which was within the specification limits of 0.0540" - 0.0570" per the catheter extrusion graphic.The outer diameter of the distal extension line measured 0.0945" which was within the specification limits of 0.0930" - 0.0970" per the distal extension line graphic.Both these measurements were done via calibrated caliper.The inner diameter (id) of the distal extension line measured 0.059" via calibrated pin gauge which was within the specification limits of 0.055" - 0.059" per the distal extension line graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter was connected to a lab inventory ars and flushed, and the catheter flushed as intended.The returned catheter was then tested per bs en iso which states that there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso.The catheter was connected to lab leak tester and pressurized to 300 kpa for 30 seconds.A leak was observed on the extension line towards the juncture hub, confirming the customer report.A manual tug test confirmed that the extension line was secure within its luer hub.The ifu provided with this 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." a device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that: picc inserted on (b)(6) 2023.Blood was found to be leaking from the line when flushed, during use on patient.When investigated the line was found to be fractured on the external section immediately proximal to the junction hub.The line has been removed.Additional information: there is no evidence from the device of it being pulled or stretched.No evidence of air entering vasculature.Alternate iv access was obtained and iv therapy continued.No additional intervention was required and no reported patient harm.The patient was fine post issue.

• Brand Name: ARROW PICC KIT: 4 FR X 50 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17296642
• MDR Text Key: 318853816
• Report Number: 3006425876-2023-00662
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN919406
• Device Catalogue Number: EU-25041-HPMSB
• Device Lot Number: 71F22L1654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention