MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS

Model Number	IPN039773
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported patient's picc was 8cm deep in the ventricle.The bullseye showed despite deep placement.Upon ct scan, a chest x-ray was ordered and found the tip 8cm in the ventricle.The picc team was asked to retract the picc 12cms.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
Customer reported patient's picc was 8cm deep in the ventricle.The bullseye showed despite deep placement.Upon ct scan, a chest x-ray was ordered and found the tip 8cm in the ventricle.The picc team was asked to retract the picc 12cms.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The reported complaint "bullseye showing despite deep placement" could not be confirmed based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.No case data was provided for review.A device history record review performed on the stylet did not reveal any manufacturing related issues.Without the device to evaluate and the case date to review, a probable cause could not be determined from the available information, hence no further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARROW(R) VPS(R) ACCESS KIT
• Common Device Name: CATHETER, ULTRASOUND, INTRAVAS
• 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: 17321409
• Report Number: 9680794-2023-00510
• Device Sequence Number: 17865990
• Product Code: OBJ
• UDI-Device Identifier: 10801902145779
• UDI-Public: 10801902145779
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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
• Device Model Number: IPN039773
• Device Catalogue Number: VPS-0072-BPK
• Device Lot Number: 33F23B0770
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male