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

Catalog Number	VPS-0072-BPK
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	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Report from (b)(6) received: patient had a picc from another manufacturer brand inserted on june 23rd utilizing teleflex vps g4 technology.As per picc record "tip confirmed in the lower 1/3 svc/caj as per g4 technology." picc sluggish to flush with no blood return present from both picc lumens.Withdrawal occlusion present to both picc lumens.Chest x-ray was done and tip of picc was malpositioned and located in the mid svc.External length of the picc had not changed and remained the same as insertion.The teleflex vps g4 technology utilized during the insertion had the result that the picc tip was in the lower 1/3 svc (blue bullseye obtained), but the chest xray showed the picc tip was not in the lower 1/3 svc but in the mid svc.It was reported although the mid svc is not an optimal picc tip position, it was still safe to treat the withdrawal occlusion with cath-flo, as a withdrawal occlusion cannot be left untreated.A picc exchange or new picc was not inserted at this time as the patient had limited duration left for his antibiotics.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned at the time of this report.A device history record review performed on the stylet did not reveal any manufacturing related issues.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Report from ahs canada received: patient had a picc from another manufacturer brand inserted on june 23rd utilizing teleflex vps g4 technology.As per picc record "tip confirmed in the lower 1/3 svc/caj as per g4 technology." picc sluggish to flush with no blood return present from both picc lumens.Withdrawal occlusion present to both picc lumens.Chest x-ray was done and tip of picc was malpositioned and located in the mid svc.External length of the picc had not changed and remained the same as insertion.The teleflex vps g4 technology utilized during the insertion had the result that the picc tip was in the lower 1/3 svc (blue bullseye obtained), but the chest xray showed the picc tip was not in the lower 1/3 svc but in the mid svc.It was reported although the mid svc is not an optimal picc tip position, it was still safe to treat the withdrawal occlusion with cath-flo, as a withdrawal occlusion cannot be left untreated.A picc exchange or new picc was not inserted at this time as the patient had limited duration left for his antibiotics.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17826361
• Report Number: 9680794-2023-00704
• Device Sequence Number: 2480707
• Product Code: OBJ
• UDI-Device Identifier: 10801902145779
• UDI-Public: 10801902145779
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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 Catalogue Number: VPS-0072-BPK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/17/2023
• 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: ANGIODYNAMICS BIOFLO PICC; ANGIODYNAMICS BIOFLO PICC
• Patient Sex: Unknown