MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 8"; CATHETER PERCUTANEOUS

Model Number	IPN030000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "when the user inserted a catheter over needle with a syringe from the inguinal region, the air was aspirated.Therefore, it was removed and a new kit was opened instead." no patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one introducer catheter and lidstock for evaluation.After the sample failed functional testing, the proximal end of the catheter body was microscopically examined.A small flap of extrusion was detected, which led to an adjacent hole.The flap was along the seam of the hub.The total length of the returned introducer catheter body measured to be 2.52" which is within specifications of 2.458-2.528" per product drawing.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the returned introducer catheter was used to flush and aspirate water with a lab inventory syringe.Leakage was observed adjacent to the hub.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "do not reinsert needle into introducer catheter (where provided) to reduce risk of catheter embolus." the customer report of a catheter leak was confirmed by functional testing of the returned introducer catheter.A small flap of extrusion was found adjacent to the hub, which led to a small hole.Based on this finding, manufacturing likely caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.
Event or Problem Description
It was reported "when the user inserted a catheter over needle with a syringe from the inguinal region, the air was aspirated.Therefore, it was removed and a new kit was opened instead." no patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 16 GA X 8"
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11757782
• Report Number: 3006425876-2021-00383
• Device Sequence Number: 11561396
• Product Code: DQY
• UDI-Device Identifier: 00801902101914
• UDI-Public: 00801902101914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 04/12/2021

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: No Information
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN030000
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F19J1462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1