MAUDE Adverse Event Report: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN034625
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Mdr report key (b)(4).Mdr text key (b)(4).Report number (b)(4).
Event or Problem Description
Complaint found in maude database reported as: "cvc kit wire came apart (faulty wire frayed apart) when trying to remove wire from catheter in the patient that was in the proper place".
Event or Problem Description
Complaint found in maude database reported as: "cvc kit wire came apart (faulty wire frayed apart) when trying to remove wire from catheter in the patient that was in the proper place".
Additional Manufacturer Narrative
Qn# (b)(4).Mdr report key: 12091807.Mdr text key: 259140954.Report number: 12091807.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.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• MDR Report Key: 12304488
• Report Number: 9680794-2021-00391
• Device Sequence Number: 11700248
• Product Code: FOZ
• UDI-Device Identifier: 00801902071132
• UDI-Public: 00801902071132
• Combination Product (Y/N): N
• PMA/510(K) Number: K071538
• 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): 07/26/2021

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: 06/30/2022
• Device Model Number: IPN034625
• Device Catalogue Number: ASK-15703-LDP1
• Device Lot Number: 13F20L0782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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