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

Catalog Number	DLX-35552-CURVB
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "inserter had 2 microintroducers break.The break occured between the handle of the microintroducer and the sheath portion on 2 seperate kits, and 2 seperate inserters".There was no reported patient harm or consequence.Associated complaints: (b)(4).
Event or Problem Description
It was reported that: "inserter had 2 microintroducers break.The break occured between the handle of the microintroducer and the sheath portion on 2 seperate kits, and 2 seperate inserters".There was no reported patient harm or consequence.Associated complaints: 9680794-2024-00443.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.For part number eb-01051-002 extrus: 1-l 14ga x 4-1/2" ldpe blank, lot number 34c23d0085, a nonconformance was initiated in regard to peel-away sheath tabs broke off in use.However, it cannot be determined if the findings were relevant to the reported event without the device returned for evaluation.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage.".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: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19283998
• Report Number: 9680794-2024-00442
• Device Sequence Number: 18261096
• 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): 04/16/2024

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: 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown