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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG; IRRIGATION TUBING SET, GENERAL PURPOSE Back to Search Results
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.
 
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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 Key7154345
MDR Text Key96351659
Report Number1226348-2017-11011
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K890648
Number of Events Reported1
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 Date09/30/2021
Device Catalogue Number80-1189
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/05/2017
Initial Date FDA Received12/29/2017
Supplement Dates Manufacturer Received01/08/2018
Supplement Dates FDA Received01/11/2018
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 Number1
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