MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI PICC KIT: 2L 5.5 FR X 55CM; INTRODUCER CATHETER

Catalog Number	CDC-45552-HPK1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).
Event or Problem Description
Reported as "sheath broke at the base of the hub".Additional information received states that "sheath broke while inserting into the patient at the base near the hub.All parts were removed.There was no patient harm.Sheath was removed carefully and successfully, the issue was resolved by opening an entire new kit, procedure was completed".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "sheath broke at the base of the hub".Additional information received states that "sheath broke while inserting into the patient at the base near the hub.All parts were removed.There was no patient harm.Sheath was removed carefully and successfully, the issue was resolved by opening an entire new kit, procedure was completed".

• Brand Name: ARROW AGBA PI PICC KIT: 2L 5.5 FR X 55CM
• Common Device Name: INTRODUCER CATHETER
• 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: 19595599
• Report Number: 9680794-2024-00622
• Device Sequence Number: 14467406
• Product Code: DYB
• UDI-Device Identifier: 70801902124097
• UDI-Public: 70801902124097
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122854
• 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): 05/30/2024

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: 08/31/2025
• Device Catalogue Number: CDC-45552-HPK1A
• Device Lot Number: 33F24A1369
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2024
• 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