MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 24F; FEEDING DEVICE

Model Number	000724
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2023).
Event or Problem Description
It was reported that approximately thirty-five days post gastrostomy tube placement, the tube allegedly dislodged and fell out of the patient.It was revealed that the balloon ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that approximately thirty-five days post gastrostomy tube placement, the tube allegedly dislodged and fell out of the patient.It was revealed that the balloon ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the seventh complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported tube dislodged, rupture and break issues.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.H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 24F
• 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: 10873166
• Report Number: 3006260740-2020-20588
• Device Sequence Number: 16957477
• Product Code: KNT
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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 Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGDW1641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 06/10/2021
• 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 Age: 47 YR
• Patient Weight: 42