MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN036447
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint found in maude database: "arrow - multi lumen cvc - during central line placement the guidewire bent and made the placement difficult.Placement was subsequently successful after three attempts.".
Additional Manufacturer Narrative
(b)(4).The report number is mw5103108.
Additional Manufacturer Narrative
(b)(4).The mdr report key is 12301324.The mdr text key is 266015200.The report number is mw5103108.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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
Complaint found in maude database: "arrow - multi lumen cvc - during central line placement the guidewire bent and made the placement difficult.Placement was subsequently successful after three attempts.".

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12593691
• Report Number: 9680794-2021-00511
• Device Sequence Number: 4103169
• Product Code: DQY
• UDI-Device Identifier: 20801902116776
• UDI-Public: 20801902116776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: IPN036447
• Device Catalogue Number: CDC-15703-1A
• Device Lot Number: 13F21A0323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1