MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVB
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The report of a damaged peel-away tip was confirmed through complaint investigation of the returned sample.The customer returned one peel-away sheath with dilator assembly for analysis.Signs of use were observed on the returned components.Visual analysis revealed that the distal end of the sheath tip was split and folded.Despite the damage, the sheath and the dilator met all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Therefore, the root cause was undetermined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further identify the potential root causes.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "when trying to thread sheath introducer it was getting caught up in the patient's skin at the point of transition from dilator to sheath.That transition felt thicker and stickier than usual.It started to mushroom and split.Had to pull a new sheath introducer from another kit to complete the insertion".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when trying to thread sheath introducer it was getting caught up in the patient's skin at the point of transition from dilator to sheath.That transition felt thicker and stickier than usual.It started to mushroom and split.Had to pull a new sheath introducer from another kit to complete the insertion".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: AGBA PICC NAVICURVE: 1L 4.5FR X 55CM 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19391254
• Report Number: 9680794-2024-00507
• Device Sequence Number: 6955146
• Product Code: LJS
• UDI-Device Identifier: 10801902208696
• UDI-Public: 10801902208696
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 01/24/2025
• Device Catalogue Number: DLX-45541-CURVB
• Device Lot Number: 33F23K0375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Patient Sex: Unknown