MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number H7498060100121

Device Problem Air Leak (1008)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device from the reported event has been returned to angiodynamics however, the device evaluation is in progress.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by angiodynamics' distributor in malaysia, a hospital reported that "air was being entrained into the (blood pressure transducer) manifold system with no obvious loose connection found.There was no reported patient injury." the used manifold has been returned to angiodynamics.

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 recent angiodynamics complaint report was reviewed for the perceptor manifold/compensator product family and the failure mode "air bubbles noted."no adverse trend was indicated.It was noted during the visual inspection of the returned manifold that the o-ring was missing from the rotating adaptor (ra).The root cause of the reported air in the manifold would have been due to the missing o-ring in the rotating adaptor r/a assembly on the manifold.The root cause of the missing o-ring in the stem cup was a result of operator error during the manual assembly process.This device non-conformance was not observed during the 100% visual inspection of the ra/o-ring post assembly.A department-wide re-training for manufacturing associates who work in the manual manifold assembly area has been performed on the ra swaging procedure and visual inspections per angiodynamics' procedures.This is the only reported complaint for air bubbles due to missing o-ring in the ra for the perceptor manifold/compensator product family in the past 15 months, as such, this is deemed to be an isolated incident.Risk management review shows failure mode is not occurring at a frequency greater than expected.(b)(4).

• Brand Name: ANGIODYNAMICS
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 7518355
• MDR Text Key: 108733254
• Report Number: 1317056-2018-00065
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: H7498060100121
• UDI-Public: H7498060100121
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K951722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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 Operator: Physician
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: H7498060100121
• Device Lot Number: 5225259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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