MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 1-3/4"; CATHETER, PERCUTANEOUS

Model Number	IPN914813
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Catheter hub was cracked and was leaking.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided one video for analysis.The complaint of an arterial catheter leaking was able to be confirmed by the video.Blood was observed leaking out of the catheter hub.A complete visual inspection could not be performed as no sample was returned for analysis.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 instructions for use (ifu) provided with this kit warns the user, "do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations." without the device to evaluate, 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
Catheter hub was cracked and was leaking.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4"
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12979083
• Report Number: 9680794-2021-00663
• Device Sequence Number: 4278207
• Product Code: DQY
• UDI-Device Identifier: 10801902158144
• UDI-Public: 10801902158144
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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
• Device Model Number: IPN914813
• Device Catalogue Number: ASK-04020-UOI1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown