MAUDE Adverse Event Report: COOK INC ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	G34443
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an entuit start initial placement gastrostomy tube burst and came out of a patient.To date, additional information regarding the patient and event is unknown.
Additional Manufacturer Narrative
On 03sep2018, the associated cook inc.Representative reported additional information.The initial device code was reported to cook inc.Incorrectly.The complaint device is an sbrd in which xeridiem is the labeled manufacturer.The labeled manufacturer is responsible for all regulatory reporting and complaint investigation requirements.

• Brand Name: ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7516082
• Report Number: 1820334-2018-01409
• Device Sequence Number: 19125038
• Product Code: KNT
• UDI-Device Identifier: 00827002344433
• UDI-Public: (01)00827002344433(17)201220(10)8459652
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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 Model Number: G34443
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1