MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number	IPN033092
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The extension line was separating from the hub and leaking during use.Device inserted (b)(6) 2020 and removed (b)(6) 2021.The catheter was replaced.No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Continuation of d11: row infusion (b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The photos confirmed that there was a hole in the proximal extension line adjacent to the luer hub.However, a full visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of leaking extension line was confirmed by visual inspection of the customer supplied photos.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on sales history, and no relevant findings were identified.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
The extension line was separating from the hub and leaking during use.Device inserted (b)(6) 2020 and removed (b)(6) 2021.The catheter was replaced.No patient injury or harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11383095
• Report Number: 3006425876-2021-00175
• Device Sequence Number: 2384823
• Product Code: DQY
• UDI-Device Identifier: 10801902099690
• UDI-Public: 10801902099690
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: No Information
• Device Model Number: IPN033092
• Device Catalogue Number: CS-16553-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMO, SERUM, ANTIBIOTIC, BLOOD COMPONENTS AND MAR; CHEMO, SERUM, ANTIBIOTIC, BLOOD COMPONENTS AND MAR