MAUDE Adverse Event Report: MICROTEK DOMICANA, S.A WARMER DRAPE; FLUID WARMING AND SLUSH DRAPES

Model Number ORS-100

Device Problem Strikethrough (2538)

Patient Problem No Code Available (3191)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed at the manufacturing site in the (b)(4).Based on the dmr reviewed, product number ors-100, lot number d152311 had (b)(4) pieces that were manufactured on 08/18/2015.No defects were reported in process, packaging or final inspection.The investigation revealed that this problem was not due to an assembly, material, or process issue.No product has been returned.Since no device was returned for analysis, the root cause for the event has not been determined.

Event Description

An end user found that a warmer drape had a hole in it.The drape was removed and not used on the patient.A new drape from the same lot was opened; there was no hole in the second drape.The report was for part number ors-100, lot number 1037708.Because the drape was not use on the patient, it appears there was no adverse event.

• Brand Name: WARMER DRAPE
• Type of Device: FLUID WARMING AND SLUSH DRAPES
• Manufacturer (Section D): MICROTEK DOMICANA, S.A; zona franca, la romana ; DR
• Manufacturer (Section G): MICROTEK DOMICANA, S.A; zona franca, ; DR
• Manufacturer Contact: pichsoth kim ; 370 wabasha street north; st. paul, MN 55102 ; 6512502886
• MDR Report Key: 5224017
• MDR Text Key: 31186164
• Report Number: 8043817-2015-00008
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/18/2020
• Device Model Number: ORS-100
• Device Lot Number: D132311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1