MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MEDIPLEX SEJONG HOSPITAL; CATHETER INTRAVSCULAR THERAPEU

Model Number	IPN037301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: picc nurse was alerted to a leak/hole in picc placed on (b)(6) 2021.The hole is just beneath the pink hub.It was reported the line was discontinued.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: picc nurse was alerted to a leak/hole in picc placed on 1(b)(6) 2021.The hole is just beneath the pink hub.It was reported the line was discontinued.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen picc for evaluation.Signs-of-use were observed inside the extension lines.The catheter body was intentionally severed below the 36cm mark.The severed portion was not returned for analysis.Visual inspection of the distal extension line confirmed a hole adjacent to the luer hub.This damaged is consistent with the molding defect seen on picc extension lines.The distal luer hub was cross sectioned to examine the portion of the extension line inside of the hub.No obvious defects or anomalies were observed.The catheter body length from the juncture hub to the severed end measured 14.4375" which indicates that at least 8.3125"-8.5625" were separated and not returned for analysis.The outer diameter of the distal lumen measured to be 0.0938" which is within specifications of 0.0930"-0.0970" per distal extension line extrusion product drawing.The inner diameter of the distal extension line measured to be 0.055" which is within specifications of 0.055"-0.059" per distal extension line extrusion product drawing.This indicates that the wall thickness measured as expected.The extension lines were initially flushed per ifu which states, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." with the distal end of the catheter occluded, the extension lines were pressurized using a water-filled lab inventory syringe.When the distal line was pressurized, water leaked from the hole in the distal extension line/luer hub.No leaks were detected in the proximal line.A manual tug test confirmed both extension lines were fully secured within their luer hubs.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce the risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line(s) from excessive pressure." the complaint of an extension line leak was confirmed through complaint investigation of the returned sample.A hole was found in the distal extension line adjacent to the luer hub.The returned sample passed all relevant dimensional inspections.A device history record review was performed, and no relevant findings were identified.The type of damage observed is consistent with a manufacturing issue in the picc lines.A non-conformance has been initiated to further investigate this issue.

• Brand Name: ARROW MEDIPLEX SEJONG HOSPITAL
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12226907
• Report Number: 9680794-2021-00365
• Device Sequence Number: 1323716
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 05/31/2022
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F21A0668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED