MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 12F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000712
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the healthcare professional attempted to inject sterilized water into the balloon and the balloon did not inflate due to alleged cracks in the device.There was no reported patient injury.
Event or Problem Description
It was reported that the healthcare professional attempted to inject sterilized water into the balloon and the balloon did not inflate due to alleged cracks in the device.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records review is not available because the corporate lot number is unknown.The sample returned for evaluation was one 12 fr tri-funnel replacement gastrostomy feeding tube.Visual evaluation was performed of the physical sample.The sample was returned with a 0.8 cm long split in the balloon material, approximately 0.9 cm from the distal tip of the device.Examination of the split site revealed it to be c-shaped, with the split surface being dull in appearance.The surrounding material near the split site appeared to have a distended shape memory.The observed damage is consistent with a burst due to over-pressurization.Therefore, the investigation is unconfirmed for inflation problem and confirmed for burst container or vessel.A review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 12F
• 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: 7741282
• Report Number: 3006260740-2018-01900
• Device Sequence Number: 1076560
• Product Code: KNT
• UDI-Device Identifier: 00801741037115
• UDI-Public: (01)00801741037115
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 000712
• Device Catalogue Number: 000712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1