MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC: 1-L 4.5 FR X 45 CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN038494
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Clinician noticed a pin hole in lumen extension tubing, approximately where it meets the extension set lumen hub.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, 1-l picc catheter for analysis.Signs of use in the form of biomaterial was observed inside the extension line.Visual analysis revealed that the extension line contained a hole directly adjacent to the luer hub (pink hub).The appearance of the defect seems consistent with damage due to a manufacturing defect.The catheter body length measured 18 1/16" which is within the specification limits of 17 11/16"-18 3/16" per the coated catheter product drawing.The distal extension line inner diameter measured 0.056" which is within the specification limits of 0.055"-0.059" per the distal extension line extrusion product drawing.The distal extension line outer diameter measured 0.0945" which is within the specification limits of 0.093"-0.097" per the distal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to the catheter luer hub and flushed.Water was observed leaking out of the hole in the extension line.Performed per ifu statement "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit cautions the user, "do not exceed ten (10) injections or the maximum pressure of 300 psi on power injector equipment to reduce the risk of catheter failure and/or tip displacement".The ifu also states, "ensure patency of intended pressure injectable lumen of catheter prior to pressure injection to reduce the risk of catheter failure and/or patient complications." the customer report of a leaking extension line was confirmed through complaint investigation.Visual analysis revealed a hole in the distal extension line directly adjacent to the luer hub (pink hub).Water leaked from the hub during functional analysis.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Clinician noticed a pin hole in lumen extension tubing, approximately where it meets the extension set lumen hub.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC: 1-L 4.5 FR X 45 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: 13055540
• Report Number: 9680794-2021-00677
• Device Sequence Number: 11178046
• Product Code: LJS
• UDI-Device Identifier: 10801902140781
• UDI-Public: 10801902140781
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 10/31/2022
• Device Model Number: IPN038494
• Device Catalogue Number: ASK-44541-ABKB
• Device Lot Number: 13F21H0481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/19/2022
• 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
• Patient Sex: Unknown