MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05042
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "in the picc catheter placement procedure for a pediatric patient, a pediatric surgeon, proceeds to open the packaging of the sterile device, then takes the introducer needle to puncture the patient's upper extremity in the basilic vein.However, it presented problems on the introduction and resistance in entry; 3 attempts are made, and when observing the bevel on the prominent tip, a deviation (bent) is observed; which can cause resistance when the needle enters the venous capital".
Event or Problem Description
It was reported that "in the picc catheter placement procedure for a pediatric patient, a pediatric surgeon, proceeds to open the packaging of the sterile device, then takes the introducer needle to puncture the patient's upper extremity in the basilic vein.However, it presented problems on the introduction and resistance in entry; 3 attempts are made, and when observing the bevel on the prominent tip, a deviation (bent) is observed; which can cause resistance when the needle enters the venous capital".Additional information reported that the patient was fine and the device was replaced to resolve the issue.
Additional Manufacturer Narrative
(b)(4) the customer returned an opened, two-lumen picc kit containing an introducer needle, peel-away sheath, dilator, catheter, guidewire, clamps, statlock device, and dust caps.Visual analysis of the 21ga.Introducer needle revealed that the tip was damaged.Microscopic examination confirmed the damage and revealed that the tip was folded outward.Microscopic examination also revealed that the inside of the needle guard was scratched.The inner diameter of the needle cannula at the distal and proximal ends measured 0.023", which is within the specification limits of 0.0226" - 0.0240" per the cannula product drawing.The cannula outer diameter measured 0.032", which is within the specification limits of 0.0320" - 0.0325" per the cannula product drawing.The length of the needle cannula measured 2 15/16", which is within the specification limits of 2.908" - 3.052" per the needle product drawing.A device history record review was performed, and no relevant findings were identified.The report of a damaged needle tip was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the needle tip from the 21ga introducer needle was folded outward.The sample met all relevant dimensional requirements.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this failure.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC SET: 2-LUMEN 4 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21344253
• Report Number: 9680794-2025-00122
• Device Sequence Number: 15374885
• Product Code: LJS
• UDI-Device Identifier: 00801902095367
• UDI-Public: (01)00801902095367(11)240412(17)270228(10)14F24D0053(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Catalogue Number: PR-05042
• Device Lot Number: 14F24D0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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