MAUDE Adverse Event Report: DEPUY MITEK LLC US GRAVITY TUBE SET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Catalog Number	281113
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate the complaint device was received and evaluated.Visual inspection revealed that the fittings are not secured into the bulb.The devices were and tested.The fittings in the ends of the bulbs where not glued properly per the drawing and could be slid into and out of the bulb.This would allow the saline solution to leak from the bulb when it was squeezed.This compliant can be confirmed.A nc was opened to track this failure.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed two similar and one dis-similar complaints for this lot of devices that were released to distribution.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales rep reported via phone that the customer's 1113 gravity tube set was leaking where the bulb and tube connect prior to a shoulder scope.The case was completed with another like device.There were no patient consequences or delays.The device is being returned.

• Brand Name: GRAVITY TUBE SET 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7816662
• Report Number: 1221934-2018-53841
• Device Sequence Number: 11374206
• Product Code: HRX
• UDI-Device Identifier: 10886705015856
• UDI-Public: 10886705015856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 281113
• Device Lot Number: 2576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/27/2018
• Patient Sequence Number: 1