MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Catalog Number	CDC-45552-VPS2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc team received a call friday that hub had fallen off.The staff member did not observe the hub falling off, she discovered it.Picc nurse pulled line and replaced with a new catheter." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, severed proximal luer hub.Signs of use in the form of biological material were observed inside the luer hub.Visual analysis revealed that the proximal extension line was severed directly adjacent to the luer hub.Microscopic examination confirmed the damage and revealed that the edges were jagged.Visual analysis could not be performed on the rest of the proximal extension line nor the catheter to evaluate the nature of the break as the rest of the catheter was not returned.The proximal extension line inner diameter (at the point of separation) measured 0.058", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.No other dimensional specification could be verified as no other portion of the catheter was returned for analysis.Functional testing could not be performed as part of this complaint investigation as only the severed hub was returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of a separated extension line luer hub was confirmed through complaint investigation.Visual analysis revealed that the proximal line was severed directly adjacent to the white luer hub; however, a full visual, dimensional, or functional analyses could not be performed as the remainder of the catheter was not returned.A device history record review was performed with no relevant findings.Without the entire catheter returned for analysis, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "picc team received a call friday that hub had fallen off.The staff member did not observe the hub falling off, she discovered it.Picc nurse pulled line and replaced with a new catheter." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• 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: 19069431
• Report Number: 9680794-2024-00323
• Device Sequence Number: 6825999
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 03/18/2024

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: 12/31/2024
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 33F23K0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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