MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F; FEEDING DEVICE

Model Number	000720
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, a picture is provided for review the investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that the balloon of the gastrostomy tube allegedly ruptured approximately one month and twenty three days post placement.Reportedly it was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one tri-funnel replacement gastrostomy tube and two electronic photos were provided for review.Gross, microscopic visual observation and functional testing were performed.The investigation is confirmed for the reported fluid leak and fracture issue as the balloon was inflated with approximately 20ml of water and a leak was noted at the circumferential split observed approximately 2.4cm distal end of the device.However, the investigation is inconclusive for the reported spontaneous exit of probe as the exact circumstances at the time of reported event are unknown.A definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2023), g3.H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the balloon of the gastrostomy tube allegedly ruptured approximately one month and twenty three days post placement.Reportedly it was removed.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10666952
• Report Number: 3006260740-2020-20058
• Device Sequence Number: 4283899
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 01/01/2023
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Device Lot Number: NGDU1295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 54