MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW DRAINAGE SET; CATHETER IRRIGATION

Catalog Number	AI-01600
Medical Device Problem Codes	Crack (1135); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on 21/5/2024 dr (pulmonogist) opened pack to use on patient and noted needle broken in set.Packaging was not damaged." the returned device showed a crack in the needle hub.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened percutaneous cavity drainage catheterization kit for analysis.Signs of use in the form of what appears to be biological material were observed inside the needle cannula at the bevel.A reddish-pink residue was also observed inside the tray of the kit.Visual and microscopic examination confirmed that the hub of the 18ga introducer needle was cracked.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin".The customer report of a cracked needle hub was confirmed by visual inspection of the customer supplied photo and the returned sample.Visual analysis revealed a crack on the needle hub.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the capa investigation , the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The capa was fully implemented (b)(6) 2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2024 dr (b)(6) opened pack to use on patient and noted needle broken in set.Packaging was not damaged." the returned device showed a crack in the needle hub.Associated complaints 3003898360-2024-01158, 3003898360-2024-01161, 3003898360-2024-01160 and 9680794-2024-00914.

• Brand Name: ARROW DRAINAGE SET
• Common Device Name: CATHETER IRRIGATION
• 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: 20117116
• Report Number: 9680794-2024-00914
• Device Sequence Number: 7447117
• Product Code: GBX
• UDI-Device Identifier: 00801902097903
• UDI-Public: (01)00801902097903(11)230607(17)280531(10)33F23F0019(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K895516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Catalogue Number: AI-01600
• Device Lot Number: 33F23F0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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