MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Model Number	IPN914769
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the needle (the metal part) has detached from the plastic ll connection during the puncture of the vein singularis externa.The metal part could be removed from the patient.The patient was not harmed." at the time of this report the patient remained hospitalized for surgical complications.
Event or Problem Description
It was reported that "the needle (the metal part) has detached from the plastic ll connection during the puncture of the vein singularis externa.The metal part could be removed from the patient.The patient was not harmed." at the time of this report the patient remained hospitalized for surgical complications.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned an opened cvc kit containing introducer needle and syringe for analysis.Both components showed evidence of use.Visual analysis revealed that the needle cannula had become completely dislodged from the needle hub.There was a small amount of adhesive residue observed on the needle cannula, but none in the needle hub.This signifies that manufacturing likely caused or contributed to this event.The needle cannula outer diameter measured 0.04985" which is within the specification limits of 0.0495-0.0505" per the cannula graphic.The inner diameter of the hub measured.059" which is within the specification limits of.0585"-.0605" per the hub graphic.The needle cannula was able to be easily removed and re-inserted into the needle hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit states: "do not attempt to remove needles that have been placed into sharpsaway ii locking disposal cup.These needles are secured in place.Damage may occur to needles if they are forced out of disposal cup." the reported complaint that the needle cannula detached from the hub was confirmed through complaint investigation.The needle cannula had become completely dislodged from the needle hub.There was a small amount of adhesive residue observed on the needle cannula and inside the needle hub.This signifies that manufacturing likely caused or contributed to this event.A non-conformance has been initiated to further investigate this issue.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12961625
• Report Number: 3006425876-2021-01116
• Device Sequence Number: 13891036
• Product Code: DQY
• UDI-Device Identifier: 30801902157967
• UDI-Public: 30801902157967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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 Expiration Date: 11/30/2025
• Device Model Number: IPN914769
• Device Catalogue Number: CV-14703
• Device Lot Number: 71F21D0666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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