MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the doctor found the swg kinked during used on the patient." they changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is rported as "fine".
Additional Manufacturer Narrative
(b)(4).The report of a kinked guide wire could not be confirmed through examination of the returned sample.The customer returned an opened cvc kit including one guide wire within its advancer, an arrow raulerson syringe (ars), and 18ga introducer needle for evaluation.The guide wire was returned within the advancer tube and no obvious signs of use were observed.The guide wire was observed to have no kinks on the body.No other defects or anomalies were observed on the returned components.Additionally, the returned guide wire did not match dimensional specifications of the guide wire provided in the reported finished good as the customer reported the incorrect finished good and batch number.The guidewire passed the functional test specifications.A device history record review did not identify any manufacturing related issues.Based on the customer description and the sample received, no problem was found on the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported, "the doctor found the swg kinked during used on the patient".They changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is rported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19190627
• Report Number: 3006425876-2024-00394
• Device Sequence Number: 8426301
• Product Code: DQY
• UDI-Device Identifier: 40801902127714
• UDI-Public: 40801902127714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• 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): 04/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2025
• Device Catalogue Number: CS-15703-E
• Device Lot Number: 71F20A2402
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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: Unknown