MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported "catheter that at the moment of inserting and purging again it is observed that it is broken in the and where the two lines divide".A new catheter was inserted.The patient "had no negative consequences".
Additional Manufacturer Narrative
(b)(4).The customer report of a cracked juncture hub was confirmed by visual inspection of the customer supplied photo and sample received.The customer provided one photo for analysis.The complaint of a crack in the juncture hub was confirmed by the photo.The customer returned multiple components of a picc kit, including one 2-l catheter, guide wire assembly, needle, and product lidstock for analysis.No definite signs of use were observed.Visual analysis revealed that the juncture hub of the catheter contained a hole.The edges of the hole appeared to be jagged.Due to the hole, a portion of the catheter extrusion was exposed within the juncture hub.Functional analysis was performed per the instructions-for-use (ifu) provided with this kit which instructs the user, "flush lumen(s) with sufficient volume of solution to completely clear blood.".Both lumens were flushed using a lab inventory syringe, and both flushed as intended.The returned catheter was then tested per bs en iso which states that there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso.The catheter was connected to lab leak tester (leak tester: ref-002902) and pressurized to 300 kpa for 30 seconds (timer: ref-003150).No leaks were observed from any region of the catheter.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "catheter that at the moment of inserting and purging again it is observed that it is broken in the and where the two lines divide".A new catheter was inserted.The patient "had no negative consequences".

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17504388
• Report Number: 9680794-2023-00575
• Device Sequence Number: 6514006
• Product Code: LJS
• UDI-Device Identifier: 10801902095371
• UDI-Public: 10801902095371
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 03/31/2023
• Device Catalogue Number: PR-05052
• Device Lot Number: 14F21D0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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 Age: 58 YR
• Patient Sex: Unknown