MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN926825
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we noticed the damage when trying to insert the cvc over the swg.The cvc was then not used and replaced with another one.There was no damage to the patient.As no use of force was applied by the anesthesiologist, we assume that the cvc was removed from the packaging in exactly this condition".The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "we noticed the damage when trying to insert the cvc over the swg.The cvc was then not used and replaced with another one.There was no damage to the patient.As no use of force was applied by the anesthesiologist, we assume that the cvc was removed from the packaging in exactly this condition".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The report of a damage dilator tip was confirmed through complaint investigation.Visual analysis revealed that the catheter tip was torn/split.Microscopic examination confirmed the damage and revealed that the edges were rough/jagged.Despite the damage, the catheter met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect was detected during use, and the comments from the manufacturing facility, the root cause for this complaint cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "we noticed the damage when trying to insert the cvc over the swg.The cvc was then not used and replaced with another one.There was no damage to the patient.As no use of force was applied by the anesthesiologist, we assume that the cvc was removed from the packaging in exactly this condition".The patient status is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18373594
• Report Number: 3006425876-2023-01263
• Device Sequence Number: 7806044
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: (01)10801902029017(11)230404(17)271031(10)71F23C2071(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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 Model Number: IPN926825
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F23C2071
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/16/2024; Not provided
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/19/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Patient Sex: Unknown