MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H965606919071

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

As no lot number was provided, a ship history report (shr) was generated for item number (b)(4) in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The february 2018 angiodynamics complaint report was reviewed for the manifold and convenience kit product families for the failure mode "air noted." no adverse trend was indicated.Examination of the returned sample confirmed the reported issue.The root cause of air in the system was caused by a damaged o-ring in the rotating adaptor (ra) assembly on the manifold.The damaged o-ring is a result of the o-ring being placed at an angle inside the manifold body stem cup.Correct orientation of the o-ring in the stem cup is horizontal, lying flat in the bottom of the stem cup.With the o-ring tilted, it allows the o-ring to be damaged by the rotating adaptor (ra) component as it was assembled onto the stem cup and swaged.When the rotating adaptor (ra) is placed onto the stem cup with a tilted o-ring a portion of the o-ring may be forced into the lumen below the stem cup or the o-ring may be cut.The root cause of the o-ring being placed in the stem cup at an angle was a result of operator error during the manual assembly process.Tooling for applying the o-ring into the stem cup of the manifold body and the swage machine for the swaging process of the ra were reviewed.No issues were discovered.To heighten the awareness of the component with air observed from the rotating adaptor, and as no specific lot number was identified by the customer, all employees in the responsible department have been notified of this complaint and the applicable re-training is being conducted.Manufacturing process controls for the manifold include multiple steps in which 100% visual inspection is performed to inspect the o-rings for damage, improper placement/seating and breakage.Additionally, an aql air leak test is performed on the manifold during the final inspection.(b)(4).

Event Description

As reported by angiodynamics' distributor in (b)(4), "air leakage was observed from the rotating adaptor of the manifold" provided in a convenience kit.No patient injury or complications were reported.The used device has been returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 7370648
• MDR Text Key: 103729785
• Report Number: 1317056-2018-00031
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H965606919071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1