MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 DAY TUBE SET (3); ARTHROSCOPE

Model Number 7211007

Device Problems Leak/Splash (1354); Pressure Problem (3012)

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

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

There was no hospitalization required.No outcomes attributed to this event.

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that the device had some issues of overpressure, causing leaking that squirted up to the ceiling.There was no delay or patient injury reported.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: DYONICS 25 DAY TUBE SET (3)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. me7ridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7667200
• MDR Text Key: 113586570
• Report Number: 1643264-2018-00519
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: (01)03596010543608(17)200930(10)50688195
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 7211007
• Device Catalogue Number: 7211007
• Device Lot Number: 50688195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/06/2018
• Supplement Dates Manufacturer Received: 07/04/2018; 08/03/2018
• Supplement Dates FDA Received: 07/10/2018; 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2017
• 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
• Patient Outcome(s): Hospitalization