MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030123
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "kinking of guidewire after placing catheter".Cvc inserted in right ijv.Patient condition is reported as fine.The device was replaced.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
The complaint is reported as: "kinking of guidewire after placing catheter".Cvc inserted in right ijv.Patient condition is reported as fine.The device was replaced.
Additional Manufacturer Narrative
(b)(4).The customer returned one cvc kit containing a catheter, box clamp, and catheter over needle assembly.No spring wire guide (swg) was returned.No signs of use were present on the returned components.A 0.032" lab inventory swg was inserted into the catheter per ifu which states, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." the swg was able to pass through the returned catheter with no issues.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." complaint verification testing could not be performed as no swg was returned for analysis.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
The complaint is reported as: "kinking of guidewire after placing catheter".Cvc inserted in right ijv.Patient condition is reported as fine.The device was replaced.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11246059
• Report Number: 3006425876-2021-00080
• Device Sequence Number: 19722495
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: 00801902102218
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K900263
• 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,Followup
• Report Date (Section B): 01/12/2021

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: 12/27/2021
• Device Model Number: IPN030123
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F20B1187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 05/17/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/24/2021; 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 73