MAUDE Adverse Event Report: SEISA MEDICAL SALES, LLC COLLECTION SET TUBING PVC (10/PK); TUBING SET

Model Number 23116

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation; however, a photographic image of the sterile packaging was provided by the user facility.The image illustrated the pvc tubing and a foreign material remained inside the packaging.Since the pvc tubing and its sterile packaging were not returned the foreign material cannot be confirmed as organic.If the device is returned to olympus for evaluation at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during setup of the procedure, the unopened package of the sterile device was noted to have some debris inside.The package remains sealed.There was no patient involvement; therefore, no patient injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information from the original equipment manufacture (oem) and to correct section e4.The oem conducted a photographic investigation and was able to confirm the reported debris in the device's sealed sterile packaging.A dhr review was performed on the subject device and indicated there was no issue reported related to the reported failure mode.Based on the reported information, the root cause was determined to be "due to the employees exiting & entering the gowning room at the same time, a hair fell off on an employees gown." the oem noted that the gowning procedure will be revised to implement turning inside out the gown prior to placing it on the hanger when leaving the clean room, in order to eliminated the possibilities of the hair on the product.In addition, to retraining all personal of the clean room regarding cleaning/sanitization, and revising work instructions to include implementation of air gun to properly clean the hose of contamination.

Manufacturer Narrative

This supplemental report is being submitted to provide the physical evaluation results.The device arrived sealed in its factory package.A visual inspection was performed on the returned device/packaging.The package of the device had not been opened by the user facility.The evaluation confirmed a piece of foreign material was confirmed to be inside the sealed package.

• Brand Name: COLLECTION SET TUBING PVC (10/PK)
• Type of Device: TUBING SET
• Manufacturer (Section D): SEISA MEDICAL SALES, LLC; 9005 montana avenue; el paso TX 79925
• MDR Report Key: 8521114
• MDR Text Key: 142357530
• Report Number: 2951238-2019-00744
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• PMA/PMN Number: K030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 23116
• Device Lot Number: S181605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1