MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030863
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "it was observed that there was a leak on the extension line.Maybe cut because of the clamp." the catheter was removed and replaced.It was reported there was no consequence for the patient.
Event or Problem Description
The complaint is reported as: "it was observed that there was a leak on the extension line.Maybe cut because of the clamp.".The catheter was removed and replaced.It was reported there was no consequence for the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen cvc for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination revealed all three lumens contained small markings/slits in them.Microscopic examination was performed on the two slide clamps returned.No burrs or anomalies were detected.The outer diameter of the medial lumen measured to be 2.90 mm which is within specifications of 2.90-3.00 mm per product drawing.The inner diameter of the medial lumen measured to be 2.11 mm which is within specifications of 2.11-2.21mm per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all three lumens were flushed using a water-filled lab inventory syringe.Though all three contained damage, only the medial lumen leaked.Manufacturing engineers were contacted as part of this complaint investigation.The engineers were able to replicate the damage observed by clamping the lumens using needle-holder clamps.The size of the damage observed matched the size of the jaws.Engineering indicated that this damage was likely caused by contact with a sharp object.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 ifu provided with this kit warns the user, "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 an extension line leak was confirmed by complaint investigation of the returned sample.The medial lumen contained a small slit consistent with contact with a sharp object.The device passed all relevant dimensional inspection and a device history record review was performed based on sales history with no relevant findings.Based on the damage observed and feedback from manufacturing , unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11362372
• Report Number: 3006425876-2021-00157
• Device Sequence Number: 14375553
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/05/2021

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: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/26/2021
• 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: NONE REPORTED.; NONE REPORTED.