MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM); WIRE, GUIDE, CATHETER

Model Number	IPN029791
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported "monitoring line is very pliable and it is causing false reading".It was reported "the tubing is very soft (described as similar to our iv tubing) and the diameter is larger than the regular pressure tubing.Both features caused the waveform to be dampened." the rn switched to another brand of tubing and the waveform was normal.No patient harm was reported.It was reported the patient was stable after arterial line extension tubing change.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "monitoring line is very pliable and it is causing false reading".It was reported "the tubing is very soft (described as similar to our iv tubing) and the diameter is larger than the regular pressure tubing.Both features caused the waveform to be dampened." the rn switched to another brand of tubing and the waveform was normal.No patient harm was reported.It was reported the patient was stable after arterial line extension tubing change.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 RA CATH KIT: 20 GA X 1-3/4" (4.45 CM)
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 17287199
• Report Number: 9680794-2023-00487
• Device Sequence Number: 5642098
• Product Code: DQX
• UDI-Device Identifier: 10801902144550
• UDI-Public: 10801902144550
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 06/12/2023

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 Model Number: IPN029791
• Device Catalogue Number: ASK-04020-UCL1
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/02/2023
• 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