MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 22F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000722
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of ngzk3424 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a hole was found on the balloon.No patient involvement.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the tri-funnel device is confirmed, and the cause is determined to be manufacturing-related.The device returned was one 22 ga, 20 cc tri-funnel replacement gastrostomy tube.Visual observation found very little residue on the device and no signs that the balloon had been inflated.Functional testing found that water infused through the inflation lumen exited through the orifices of the feeding lumen.Infusion of dyed water found that the communication between the main lumen and the inflation lumen occurred at the ¿y¿ where the inflation lumen branched from the main body.Microscopic evaluation discovered the hole at the y between the inflation lumen and the inflation lumen.It was visible on the inside of the main lumen and provided direct communication between the two lumens.The complaint is manufacturing related.A lot history review (lhr) of ngzk3424 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a hole was found on the balloon.No patient involvement.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 22F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7395664
• Report Number: 3006260740-2018-00582
• Device Sequence Number: 16586614
• Product Code: KNT
• UDI-Device Identifier: 00801741037160
• UDI-Public: (01)00801741037160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 000722
• Device Catalogue Number: 000722
• Device Lot Number: NGZK3424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1