MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H965606919141

Device Problem Air Leak (1008)

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

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots 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 january 2017 (b)(4) complaint report was reviewed for the convenience kit product family and the failure mode "device - air bubbles." no adverse trend was indicated.The returned components were returned with the contrast injection line (cil) attached the female luer end port of the stopcock, as opposed to being attached to the rotating adaptor, as the kit is packaged.The returned cil and stopcock were leak tested prior to being disconnected.The sample passed the leak test requirements per (b)(4) procedures.The stopcock female tapers, and female threads, and male rotating adaptor taper, as well as the cil female taper, female threads and male taper were all measured and found to meet specification.The stopcock and the cil were independently leak tested and each passed testing.The reported complaint description cannot be confirmed.There were no manufacturing related defects noted to the returned samples.The samples were evaluated and were found visually, dimensional and functionally acceptable.The end user's complaint does not appear to be a manufacturing related issue.A possible root cause may be that the end user did not adequately secure connections between the stopcock/cil or the device to which they were connecting, or that the devices not "finger tightened" prior to use as it is stated in the directions for use (dfu) provided to the customer in the reported kit.The dfu contains the following statements, "all connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards." (b)(4).

Event Description

As reported by (b)(4), while a hospital was utilizing a convenience kit comprised of a contrast injection line connected to a stopcock, "air entered into the device." there was no reported patient injury and the used device was returned to (b)(4) 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
• MDR Report Key: 6463521
• MDR Text Key: 72179003
• Report Number: 1317056-2017-00033
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: H965606919141
• Device Lot Number: 4948681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1