MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN H.F. DGNST 6MM RTBL DBL VLV; ACCESSORIES,ARTHROSCOPIC

Model Number 72200829

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that the cannula was rusty.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72200829 6mm rotatable high flow dual valve diagnostic cannula previously used in a bio-skills lab was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.This is a thirteen year old reusable instrument returned in poor condition.The surface of the device has typical etching from wear.The device indicates lack of proper maintenance and sterilizations.One stopcock valve lever was seized in place from bio-matter and subsequent oxidation.Per instructions for use: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but are not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc.Remove soil from challenging design features with cleaning brushes.Scrub interfaces, cannulations, and holes with a tight fitting brush using a twisting action.If possible, retract or move components to access and clean these areas.Scrub crevices and around hinged/mating surfaces with a brush.¿ no root cause related to the manufacture of the device was confirmed.Complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: CANN H.F. DGNST 6MM RTBL DBL VLV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10457283
• MDR Text Key: 204537948
• Report Number: 1219602-2020-01322
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: 03596010573520
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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 Model Number: 72200829
• Device Catalogue Number: 72200829
• Device Lot Number: 50214003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1