MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"; WIRE, GUIDE, CATHETER

Model Number	IPN036984
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reports arterial line failure in the icu.Three kits had to be opened to place one catheter.All three catheters were kinked.The physician could not pass the wire through the catheter.He struggled and was able to get the wire pass in the third (last) attempt.There was no patient injury.The patient's condition is reported as fine.
Event or Problem Description
Customer reports arterial line failure in the icu.Three kits had to be opened to place one catheter.All three catheters were kinked.The physician could not pass the wire through the catheter.He struggled and was able to get the wire pass in the third (last) attempt.There was no patient injury.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one s-l arterial catheter for evaluation.Signs of use in the form of biological material were present on the catheter body.Initial visual inspection of the catheter revealed a portion of the catheter body was flattened.The flattened portion of the catheter measured 36-49 mm from the juncture hub.The total length of the catheter measured 6.0" which is within specifications of 5.8125"-6.1875" per catheter graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "thread tip of catheter over spring wire guide (swg)." a lab inventory 0.025" diameter (measured to be 0.02440") swg was attempted to be inserted into the returned catheter.The swg met resistance at the flattened portion of the catheter and was not able to pass through.Packaging engineers were contacted to identify a potential root cause of the flattened portion of catheter.Based on their feedback the catheter was likely damaged prior to being placed in the kit since the catheter would have been protected in its individual cavity during packaging and shipping.Additionally, if the catheter was damaged during shipping, severe damage would also have been noted to the tray.Damage to the tray was not mentioned by the customer.A device history record review was performed, and no relevant findings were found.The ifu provided with this kit warns the user, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide." the complaint of a catheter bent was confirmed by complaint investigation of the returned sample.Based on the customer description, the sample returned, and feedback from packaging, this issue is likely related to manufacturing.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 12779013
• Report Number: 9680794-2021-00598
• Device Sequence Number: 5942650
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: 50801902117644
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/25/2021

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: 01/31/2023
• Device Model Number: IPN036984
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 13F21B0342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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
• Patient Sex: Unknown