MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG; IRRIGATION TUBING SET, GENERAL PURPOSE

Catalog Number 80-1189

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

Leakage was noted during preparation before the surgery with 2 complaint products.The location of hole is unknown.The device was used with cmcv.User training is done.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The products will be returned to your site.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that only one integrated tube/cord sets unitized p/n 80-1189; lot # c95551 was returned.There is a hole in the connection area/silicone-pumping segment.The hole was found in the silicone tubing and is aligned with end of the bottom connector.The actual damage is consistent with the abrasion that can occur when loading the tube set at either the upper or bottom slots of the irrigation unit.During loading of the tube sets, it is important to be aware that abrading the silicone tubing at the tube/connector transition point is possible if the tube set is loaded into the irrigation unit improperly.When loading the tubing set into the irrigation unit, the tubing should be slightly stretched so that the tube/connector transition area does not touch the slot edges.Allow then the tubing to relax into position inside the slot hole, which accepts the connector.This will minimize any abrasion of the silicone tubing during loading.A complaint of a leaking tube set from the (b)(6) market that are associated with the use of a (b)(6) only ji2000 irrigator is an anticipated issue.This risk has been evaluated and approved the (b)(6) affiliate.A review of the dhr did not show any anomalies during the manufacturing process.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG
• Type of Device: IRRIGATION TUBING SET, GENERAL PURPOSE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7154345
• MDR Text Key: 96351659
• Report Number: 1226348-2017-11011
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

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: 09/30/2021
• Device Catalogue Number: 80-1189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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