MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
When infusing, device is leaking where the lumen meets the pink luer lock.The device was removed and a new one placed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one single lumen picc for investigation.Evidence of use was observed and the catheter body appeared to be intentionally cut.Visual inspection revealed the distal extension line contained a small hole directly adjacent to the luer hub.The remainder of the extension line was secured inside the luer hub.The total length of the catheter body measured to be 17" which is not within the specification of 22.75" - 23" per product drawing.This indicates that at least 5.75" of the catheter were cut and not returned for analysis.The outer diameter of the distal lumen measured to be 0.09424" which is within specifications of 0.093" - 0.097" per product drawing.The inner diameter of the distal lumen measured to be 0.057" which is within specifications of 0.055" - 0.059" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "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." water leaked out of the hole in distal line.A device history record review was performed with no relevant findings.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 risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the complaint of an extension line leak was confirmed through a complaint investigation on 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 request has been initiated to further investigate this issue.
Event or Problem Description
When infusing, device is leaking where the lumen meets the pink luer lock.The device was removed and a new one placed.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13047119
• Report Number: 9680794-2021-00673
• Device Sequence Number: 11200216
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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
• Device Expiration Date: 12/31/2022
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F21H0882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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: Unknown