MAUDE Adverse Event Report: CONMED MEXICO 10K ARTHROSCOPY INFLOW/OUTFLOW TUBE SET; CATHETER, IRRIGATION

Catalog Number 10K150

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The product has not yet been returned for evaluation.When the device is returned, conmed will perform an evaluation and upon completion will file a supplemental medwatch report.

Event Description

The distributor in (b)(6) reported that during receiving and inspection of incoming products, a crease was found in the sealing area of 36 sterile packages containing the 10k arthroscopy inflow/outflow tube sets.There was no patient involvement as this was found prior to distribution to an end user.

Manufacturer Narrative

Conmed received (36) 10k150 tubing sets with lot number 201609074 for evaluation.Visual examination of the returned packages determined that all 36 packages exhibit creases in the bottom section of the chevron area of the pouches.This condition may be the result of extreme stresses during shipping and handling.One package with the most visible issues was dye leak tested.The sample failed the dye leak test; the device was found to have a sterility breach.A review of the device history record for this lot found no abnormalities that would contribute to this issue.Of this lot containing 1500 units, there have been no other similar reports received.A 2-year review of the complaint history for this device family shows there have been 75 reports related to this failure mode.During this same 2-year time frame, approximately (b)(4) units have been sold worldwide, making the occurrence rate for this failure mode (b)(4) percent.To date, there have been no serious injuries or deaths related to this reported problem.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.An investigation has been opened to address this issue and to ensure product safety.The packaging anomaly was obvious to the distributor personnel and therefore prompted the return of the device for evaluation and replacement.As with all medical devices, examination of the products occurs multiple times prior to use (shipping/receiving, distribution, storage and immediately prior to use).Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.Additionally, the product's instructions for use (ifu) warns: if packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.

Manufacturer Narrative

Typo identified; correct manufacture date is 09/07/2016.

• Brand Name: 10K ARTHROSCOPY INFLOW/OUTFLOW TUBE SET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CONMED MEXICO; alejandro dumas ave. 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer (Section G): CONMED MEXICO; alejandro dumas ave. 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6256142
• MDR Text Key: 65373117
• Report Number: 3007305485-2017-00015
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/06/2017
• Device Catalogue Number: 10K150
• Device Lot Number: 201609074
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1