MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-45541-HPK1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: one side of the peel-away sheath broke off while attempting to separate the two halves.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: one side of the peel-away sheath broke off while attempting to separate the two halves.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
Qn#(b)(4) the report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.The customer returned one peel-away sheath for evaluation.Signs-of-use were observed.Visual inspection of the peel-away sheath revealed that one of the tabs did not tear correctly.This resulted in the extrusion to separate.Further analysis revealed that one side of the sheath was split completely separated down the entire extrusion.The sheath extrusion was additionally severed to observe the cross section.The sheath body length from the tabs to the distal tip measured 2 13/16" via calibrated ruler, which was within the specification limits of 2 5/8"-2 7/8" per the peel-away product drawing.The sheath outer diameter/inner diameter could not be accurately measured.Functional inspection could not be accurately performed due to the condition of the returned sample.A device history record review revealed few findings relevant to this issue.Based on the customer report, the sample received, and the comments from r & d, manufacturing caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18594350
• Report Number: 9680794-2024-00040
• Device Sequence Number: 20878736
• Product Code: LJS
• UDI-Device Identifier: 30801902124075
• UDI-Public: 30801902124075
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/03/2024

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
• Device Expiration Date: 09/13/2024
• Device Catalogue Number: CDC-45541-HPK1A
• Device Lot Number: 33F23E0665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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