MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC:2L 5FR X 55CM PRELOAD VPS STYLET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-35552-VPS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the clinician was able to break apart, peel-away, & remove the sheath from the insertion site, after the picc was fully placed without issue, but experienced a little resistance, requiring more effort to break it apart" no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one peel away sheath for analysis.Definite signs of use were observed.Visual analysis revealed that the sheath was completely torn down both score lines.The appearance of the separation at the score lines was not smooth , which entails that the sheath did not peel as intended.This observation is consistent with the customer report that they "experienced a little resistance, requiring more effort to break it apart".The overall length of the sheath measured 2 13/16", which within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The outer and inner diameters of the sheath could not be accurately measured due to the condition of the returned sample.Functional testing could not be performed due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.The customer report of peel away sheath tearing incorrectly was confirmed through investigation of the returned sample.The sheath was torn completely down both score lines, but the appearance of the score lines was not smooth.This supported the customer report that they experienced resistance when peeling the sheath.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was created to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "the clinician was able to break apart, peel-away, & remove the sheath from the insertion site, after the picc was fully placed without issue, but experienced a little resistance, requiring more effort to break it apart" no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC:2L 5FR X 55CM PRELOAD VPS STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18962823
• Report Number: 9680794-2024-00263
• Device Sequence Number: 20669682
• Product Code: LJS
• UDI-Device Identifier: 30801902123801
• UDI-Public: 30801902123801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: CDC-35552-VPS
• Device Lot Number: 33F23F0374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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
• Patient Sex: Unknown