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

Catalog Number 72200830

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Property Issue (3008)

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

Event Date 10/06/2014

Event Type  No Answer Provided  

Manufacturer Narrative

No adverse event or device malfunction reported.Report of rusted/discolored pin.One device was returned for evaluation.The device was visually evaluated and the rear pin is identified to be discolored.A phenolphthalein presumptive blood test was administered to the discolored area and the presence of blood was confirmed.In addition to dried blood residue, rust was also observed.Other discolored areas of the returned device were evaluated and it was visually confirmed that blood residue is present on other areas the device such as the wells of the stop cock valves.The device rear pin was cleaned using a germicidal cleaner to remove any additional dried blood residue and it was observed that the base material is pitted and damaged.Due to the observed blood residue on the rear pin and other areas as well as the resultant rust damage observed on the rear pin the root cause has been identified to be inadequate cleaning.Per the device ifu "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." (b)(4).

Event Description

Rust a screw on the outside of the cannula looks rusted.Additional information received on 11 nov.2014 indicates that the customer washes the instruments in aseptizyme & then run them through the washer.

• Brand Name: CANN, H.F.,DGNST, 6MM, RTBL, SGL VLV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585738
• MDR Report Key: 5224300
• MDR Text Key: 31417963
• Report Number: 1219602-2015-01177
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200830
• Device Lot Number: 50506972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1