MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 4FR X 7CM GLIDETHRU SHEATH/DILATOR; NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	PL-00740
Medical Device Problem Codes	Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: after the picc was successfully inserted, the nurse tried to peel away the sheath.One of the handles broke off and she couldn't properly separate the sheath.She slowly separated it from the picc using her hands and was able to complete the procedure.Additional information: the sheath was removed from the vessel in its entirety.There was no harm or consequence to the patient.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a peel away sheath tearing incorrectly was able to be confirmed by the photo.Due to the incorrect tearing of the sheath extrusion, the photo revealed that one of the tabs became completely separated.A device history record review was performed, and no relevant findings were identified.The customer report of a peel away sheath tearing incorrectly was confirmed by visual inspection of the customer supplied photo.Visual analysis of the photo revealed that the peel-away sheath extrusion body was torn incorrectly.Based on the customer report and customer provided photo manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: after the picc was successfully inserted, the nurse tried to peel away the sheath.One of the handles broke off and she couldn't properly separate the sheath.She slowly separated it from the picc using her hands and was able to complete the procedure.Additional information: the sheath was removed from the vessel in its entirety.There was no harm or consequence to the patient.

• Brand Name: 4FR X 7CM GLIDETHRU SHEATH/DILATOR
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 18463116
• Report Number: 9680794-2024-00041
• Device Sequence Number: 14224937
• Product Code: FMI
• UDI-Device Identifier: 00801902080240
• UDI-Public: 00801902080240
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K041153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: PL-00740
• Device Lot Number: 14F23H0314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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