MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION; GASTOSTOMY TUBE

Model Number	70-0060-118
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Precise event date is not known.Model number is xeridiem part number.Catalog number is part number for xeridiem's exclusive distributor for the device, cook medical.Precise implant/explant dates are not available.User facility (b)(6) filed medwatch report mw6076060.Code chosen for conclusion represents the known issue even with no device returned.The issue is resolved with the change recently cleared in k171347.Xeridiem is presently working through production implementation of this change.
Event or Problem Description
Over the past several weeks, (b)(6) has had numerous patients with entuit gastrostomy tube return to our facility due to the "enfit" caps breaking on the tubes that were placed.This defect presents a delay in patient care, as well as a potential risk for infection.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Common Device Name: GASTOSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson,
• MDR Report Key: 7441807
• Report Number: 2025851-2018-00004
• Device Sequence Number: 1718772
• Product Code: PIF
• UDI-Device Identifier: 00827002447837
• UDI-Public: (01)00827002447837(17)181213(10)953602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130611/A01
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 12/13/2018
• Device Model Number: 70-0060-118
• Device Catalogue Number: SBRD-18-ENF
• Device Lot Number: 953602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1