MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER; GASTROSTOMY TUBE

Model Number	70-0024-020
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Problem was discovered prior to use on a patient.Model number is xeridiem's part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, boston scientific.Codes chosen reflect results and conclusion from evaluation of the returned device and package sealing process for the device.Insufficient clarity of visual work instruction for sealing process identified as likely root cause.Xeridiem is correcting the associated visual work instruction.
Event or Problem Description
When the product was being unpacked, one of the 20fr replacement g-tube, straight, was open and the device was unsterile.

• Brand Name: ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 7575399
• Report Number: 2025851-2018-00014
• Device Sequence Number: 2222133
• Product Code: KNT
• UDI-Device Identifier: 00813939020281
• UDI-Public: (01)00813939020281(17)200315(10)0976103
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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 Expiration Date: 03/15/2020
• Device Model Number: 70-0024-020
• Device Catalogue Number: M00582080
• Device Lot Number: 976103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1