MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35552-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "glide-thru sheath handles broke off during insetion of picc line".No patient harm or injury.No medical intervention required.The patient's current condition is reported as"unknown" at this time.
Event or Problem Description
It was reported "glide-thru sheath handles broke off during insertion of picc line".No patient harm or injury.No medical intervention required.The patient's current condition is reported as"unknown" at this time.
Additional Manufacturer Narrative
(b)(4).Section d.4.Unique identifier (udi)# corrected from (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and potentially relevant findings were identified.Nonconformances were created for material with batch regarding the peel-away sheath tears incorrectly failure.However, without the sample returned for analysis, it cannot be determined if this finding is relevant to the reported event.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19509300
• Report Number: 9680794-2024-00548
• Device Sequence Number: 3418467
• Product Code: LJS
• UDI-Device Identifier: 10801902208764
• UDI-Public: 10801902208764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• 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): 05/20/2024

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
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: DLX-35552-CURVB
• Device Lot Number: 33F23G0142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2023
• 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: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown