MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC: 1L 4.5 FR X 45 CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN038494
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
After physical therapy, nurse assessed the line and noted that it was "broken".Rn immediately called the vascular access team who assessed the line and removed it.Patient remained vitally stable with no blood noted in tubing.Patient denied any difficulty breathing.Occlusive dressing applied to site and new picc inserted to right cephalic vein.It was reported the patient is a full assist when doing physical therapy and the patient is unsure of what may have happened during therapy.No patient harm was reported.The patient was reported to be "stable, pending discharge" at the time of this report.
Event or Problem Description
After physical therapy, nurse assessed the line and noted that it was "broken".Rn immediately called the vascular access team who assessed the line and removed it.Patient remained vitally stable with no blood noted in tubing.Patient denied any difficulty breathing.Occlusive dressing applied to site and new picc inserted to right cephalic vein.It was reported the patient is a full assist when doing physical therapy and the patient is unsure of what may have happened during therapy.No patient harm was reported.The patient was reported to be "stable, pending discharge" at the time of this report.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one image for analysis.The image shows a catheter extrusion wrapped in dressing.The luer hub or extension line are not pictured.The customer returned one s-l catheter for analysis.The distal luer hub was not returned.Definite signs of use were observed within the extension line.Visual analysis revealed that the extension line was separated.The exact separation point of the extension line cannot be determined as the distal extension luer hub was not returned.The separation point of the extension line appears smooth, but slightly uneven.The catheter body extrusion also appears to be intentionally severed.The overall length of the catheter body measured 15 1/2" which is not within the specification limits of 18 5/8" - 18 7/8 per the catheter product drawing; therefore , 3.125" - 3.375" was not returned for analysis.The outer diameter of the distal extension line measured 0.0958" which is within the specification limits of 0.093" - 0.097" per the extrusion graphic.The inner diameter of the distal extension line measured 0.055" which is within the specification limits of 0.055" - 0.059" per the extrusion graphic.Functional testing could not be performed due to the damage to the extension line.A device history record review was performed, and a relevant finding was identified.For material c-15802-032a with lot 13c21h154, a non-conformance was created for an extension line/luer hub separation in use.Without the complete sample returned, it cannot be confirmed whether the failure modes are consistent in both cases.The instructions for use (ifu) provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of an extension line/luer hub separation was confirmed based on examination of the returned sample.Visual analysis revealed that the distal luer hub was separated from the extension line.The luer hub was not returned for analysis.The catheter passed all relevant dimensional requirements.Without the separated luer hub returned for analysis, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC: 1L 4.5 FR X 45 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 16386671
• Report Number: 9680794-2023-00083
• Device Sequence Number: 20105540
• Product Code: LJS
• UDI-Device Identifier: 10801902140781
• UDI-Public: 10801902140781
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 11/30/2023
• Device Model Number: IPN038494
• Device Catalogue Number: ASK-44541-ABKB
• Device Lot Number: 13F22K0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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 Age: 57 YR
• Patient Sex: Female