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

Model Number 23116

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2017

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 that 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.Olympus followed up with the user facility to obtain additional information regarding the reported event but with no result.As part of our investigation, the oem was requested to conduct a performance investigation.If additional information is received this report will be supplemented accordingly.

Event Description

The user facility reported that during or setup prior to opening the device sterile packaging; the nurse inspected the package and noted what appeared to be a hair inside the packaging.There was no patient involvement; therefore, no patient injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the original equipment manufacture¿s device evaluation results.The device was returned to the original equipment manufacturer (oem) for evaluation.The oem evaluation confirmed the reported event of ¿hair inside the sealed package.¿ a review of the dhr was performed and no anomalies were found.The inventory of finish goods was inspected and no issues were found.The oem determined two possible root causes of the reported event, and these are the combination of material and manpower, as there was no formal documented process which specifies the cleaning method of the container assigned for connectors, and person not following appropriate rules of gowning and hygiene procedure.

• Brand Name: COLLECTION SET TUBING PVC (10/PK)
• Type of Device: COLLECTION SET TUBING PVC
• Manufacturer (Section D): SEISA MEDICAL SALES, LLC; 9005 montana avenue; el paso TX 79925
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6341884
• MDR Text Key: 68083734
• Report Number: 2951238-2017-00098
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23116
• Device Catalogue Number: 23116
• Device Lot Number: S164210
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1