MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45703-XP1A
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On introduction of central line wire, the wire encountered an obstruction and, on withdrawing, became stuck at the tip of the introducer needle.The whole unit was removed without issue and a second attempt was made, but unable to pass again.Associated to 9680794-2023-00769.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of an unravelled guide wire through needle resistance was confirmed by visual inspection of the customer supplied photos.The photos show an unravelled guidewire partially advanced through an introducer needle with evidence of use.Based on the photos, the customer report is confirmed, however, full complaint testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." 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 monitor and trend for reports of this nature.
Event or Problem Description
On introduction of central line wire, the wire encountered an obstruction and, on withdrawing, became stuck at the tip of the introducer needle.The whole unit was removed without issue and a second attempt was made, but unable to pass again.Associated to 9680794-2023-00769.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18244551
• Report Number: 9680794-2023-00947
• Device Sequence Number: 7108332
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: 20801902117216
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/29/2023

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 Expiration Date: 06/30/2024
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F23C0776
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown