MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05042
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the first insertion is made in the basilic vein of the upper left limb.During the passage of the catheter, it is observed that it remains ascending, so it is repositioned and in this attempt it is rolled up at the level of the right subclavian, observed by means of radiological control to determine position, so the device is completely removed.The picc insertion is carried out in a second attempt that was successful, with a new device." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of a catheter kinked or bent in use cannot be confirmed by the photo.The photo was a copy of a patient x-ray which revealed that the catheter was ascending above the subclavian region rather than descending into the superior vena cava; however, there was not clear visual evidence of kinking or bending in the catheter body.No photos of the catheter outside of the patient were provided.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position.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 complaint of catheter kinked or bent in use cannot be confirmed by the customer photo.The photo was a copy of a patient x-ray which revealed that the catheter was ascending above the subclavian region rather than descending into the superior vena cava; however, there was not clear visual evidence of kinking or bending in the catheter body.No photos of the catheter outside of the patient were provided.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to m onitor and trend for reports of this nature.
Event or Problem Description
It was reported "the first insertion is made in the basilic vein of the upper left limb.During the passage of the catheter, it is observed that it remains ascending, so it is repositioned and in this attempt it is rolled up at the level of the right subclavian, observed by means of radiological control to determine position, so the device is completely removed.The picc insertion is carried out in a second attempt that was successful, with a new device." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19720242
• Report Number: 9680794-2024-00669
• Device Sequence Number: 8206554
• Product Code: LJS
• UDI-Device Identifier: 00801902095367
• UDI-Public: (01)00801902095367(11)230719(17)270228(10)14F23G0124(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Catalogue Number: PR-05042
• Device Lot Number: 14F23G0124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Male