MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one wing broke off, with all but approx 1 cm remaining in patient's arm.The nurse required 2 artery forceps to grip remaining sheath to slowly retract from patients arm, then slide up picc to hub where it started to separate and remove from picc line." the sheath was completely removed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided two images for analysis.The images confirmed a peel away sheath tearing incorrectly as incorrect tearing of the extrusion towards one tab was identified.The customer returned one peel-away sheath for analysis.No definite signs of use were observed.Visual inspection revealed that one side of the peel-away sheath tore partway down the extrusion, causing the tab and extrusion to separate from the rest of the assembly.The sheath extrusion appeared partly stretched.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down one score line.It was also identified that the blue stripe of the extrusion was not accurately aligned with the tabs to ensure proper tearing of the sheath.This likely caused or contributed to the reported defect.The sheath was severed to observe the cross section.The overall length of the sheath measured 4" which is within the specification limits of 3 7/8 - 4 1/8" per the sheath product drawing.Functional inspection could not be accurately performed as a part of this complaint investigation due to the condition of the returned sample.Manufacturing was consulted as a part of this complaint investigation.They stated that the likely cause of the defect is that that the extrusion was not correctly aligned duri ng the molding operation (blue stripes).A device history record review was performed and the following findings were identified: for part number eb-01051-002 with batch 34c23d0085, the device history records revealed 3 non-conformances regarding peel-away sheath defects.The instructions for use (ifu) provided with this kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." the report that a peel-away sheath did not tear correctly was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one side of the extrusion tore partway, causing the tab and extrusion to separate from the assembly.Microscopic examination identified that the blue stripe of the extrusion was not accurately aligned with the tabs to ensure proper tearing of the sheath.Manufacturing was additionally consulted as a part of this complaint investigation, and they confirmed that the likely cause of the defect is that the extrusion was not correctly aligned during the molding operation (blue stripes).Therefore, 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
It was reported that "one wing broke off, with all but approx 1 cm remaining in patient's arm.The nurse required 2 artery forceps to grip remaining sheath to slowly retract from patients arm, then slide up picc to hub where it started to separate and remove from picc line." the sheath was completely removed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 20771588
• Report Number: 9680794-2024-01132
• Device Sequence Number: 8088483
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)230619(17)250531(10)33F23F0433(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 05/31/2025
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F23F0433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: Unknown