MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED DORNOCH MANIFOLD; SUCTION MANIFOLD, REPROCESSED

Model Number UL-CL500

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Medline renewal received a report that a user facility recently experienced an issue with a reprocessed dornoch waste manifold, model ul-cl500r.The report stated that the hydrophobic filter fell out of the manifold, clogging the rover and reducing the suction capability of the waste management system.The device in question was not returned for evaluation, however unused, reprocessed samples were returned from the user facility to assist our investigation.The devices contain a removable hydrophobic filter, and our investigation concluded that the filter may not have been fully inserted into the manifold during the assembly process.Therefore, the filter may have become loose/dislodged during transport or use.Manufacturing technicians were retrained on the use of the assembly equipment that provides 100% verification of proper filter assembly.Although the patient did not experience any harm as a result of the device malfunction, medline renewal is submitting this medwatch report in an abundance of caution.

Event Description

Medline renewal received a report that a user facility recently experienced an issue with a reprocessed dornoch waste manifold, model ul-cl500r.The report stated that the hydrophobic filter fell out of the manifold, clogging the rover and reducing the suction capability of the waste management system.The patient did not experience any harm as a result of the device malfunction.

• Brand Name: MEDLINE RENEWAL REPROCESSED DORNOCH MANIFOLD
• Type of Device: SUCTION MANIFOLD, REPROCESSED
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6088245
• MDR Text Key: 59888393
• Report Number: 3032391-2016-00029
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UL-CL500
• Device Catalogue Number: UL-CL500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• 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?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention