MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS; INTRODUCER, CATHETER

Model Number	IPN911881
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: "during the procedure, the nurse accessed the vein with the needle and was preparing to insert the glide thru peel-away sheath then the picc.When she picked up the sheath, it was the incorrect size (5.5 french.) the catheter was also incorrect: there was a 5.5 french double lumen instead of a 4.5 french single lumen catheter.The procedure was delayed as a new kit had to be opened." no patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: "during the procedure, the nurse accessed the vein with the needle and was preparing to insert the glide thru peel-away sheath then the picc.When she picked up the sheath, it was the incorrect size (5.5 french.) the catheter was also incorrect: there was a 5.5 french double lumen instead of a 4.5 french single lumen catheter.The procedure was delayed as a new kit had to be opened." no patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer report of an incorrect catheter within the kit could not be confirmed by visual inspection of the customer supplied photo.A full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.However, further action was not required at the time of this report as the probable cause could not be confirmed based upon the information provided and without a sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS
• Common Device Name: INTRODUCER, CATHETER
• 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: 17197949
• Report Number: 9680794-2023-00454
• Device Sequence Number: 6741417
• Product Code: DYB
• UDI-Device Identifier: 10801902134988
• UDI-Public: 10801902134988
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 05/30/2023

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: 01/31/2024
• Device Model Number: IPN911881
• Device Catalogue Number: ASK-45541-VFH
• Device Lot Number: 13F22M0093
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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