MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 2-L: 5.5 FR X 50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-45052-HP
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).Udi number: (b)(4).
Event or Problem Description
It was reported "picc catheter kit dilator went bad and the guidewire bent." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number includes: 9680794-2024-00588.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows a peel-away sheath/dilator assembly with the dilator tip appearing damaged.In addition, the guide wire appeared curled and kinked.The complaint of dilator tip damaged was able to be confirmed by the photo, however, a complete visual inspection to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation and bleeding.Do not apply undue force on guidewire to minimize the risk of possible breakage." 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
It was reported "picc catheter kit dilator went bad and the guidewire bent." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number includes: 9680794-2024-00588.

• Brand Name: ARROW AM PICC SET 2-L: 5.5 FR X 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19557979
• Report Number: 9680794-2024-00587
• Device Sequence Number: 4733814
• Product Code: LJS
• UDI-Device Identifier: 10801902095722
• UDI-Public: (01)10801902095722(11)230518(17)240830(10)14F23E0004(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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 Expiration Date: 08/30/2024
• Device Catalogue Number: PR-45052-HP
• Device Lot Number: 14F23E0004
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Female