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

Model Number	000722
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	07/20/2018
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 provided, a review of the device history records is currently being performed.The device is pending return 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 balloon is not symmetrical, only covering half of the tube, and there is a leak.Another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that the balloon is not symmetrical, only covering half of the tube, and there is a leak.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: device history records used in the manufacturing of this lot did not show any rejects related with the reported issue.Investigation summary: the sample returned for evaluation was one 22 fr tri-funnel replacement gastrostomy feeding tube.Visual and functional evaluations were performed of the physical sample.The sample was returned with a circumferential split in the midsection of the balloon material.Examination of the split site revealed it to be curved.The surrounding material near the split site had a distended shape memory and a large amount of dark usage discoloration.The observed damage is consistent with a burst due to over-pressurization.Therefore, the investigation is unconfirmed for difficult to inflate and confirmed for balloon rupture.The investigation indicates that the failure is resulting from balloon rupture, and while a definitive root cause could not be determined based upon available information, procedural issues may have contributed to this event.Labeling review: 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 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: 7770326
• Report Number: 3006260740-2018-02007
• Device Sequence Number: 11259199
• Product Code: KNT
• UDI-Device Identifier: 00801741037160
• UDI-Public: (01)00801741037160
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: NGBY2221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 50