MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN055193
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "small hole between brown head and catheter to cause leaking issue".The device was removed from the right groin and a new device was placed in the left groin.No patient injury or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied a photo of a cvc extension line/luer hub.Visual analysis could not reveal any definite damage as the photo quality was blurred.A probable cause of the extension line/luer hub leak cannot be determined from the photo and without the sample to evaluate.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs 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".The report of an extension line leak could not be confirmed through examination of the customer supplied photo.The image showed a cvc extension line/luer hub; however, due to the image quality, the reported damage could not be officially confirmed.A device history record review was performed, and no relevant findings were identified.The probable cause of the extension line leak could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: "small hole between brown head and catheter to cause leaking issue".The device was removed from the right groin and a new device was placed in the left groin.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11222345
• Report Number: 3006425876-2021-00049
• Device Sequence Number: 19842840
• Product Code: FOZ
• UDI-Device Identifier: 10801902146554
• UDI-Public: 10801902146554
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Expiration Date: 05/11/2022
• Device Model Number: IPN055193
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F20F0483
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/22/2021
• 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.; NONE REPORTED.