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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
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 was returned for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that approximately one month of gastrostomy tube placement, the device allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that approximately one month of gastrostomy tube placement , the device allegedly ruptured and leakage.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one tri-funnel replacement gastrostomy tube was returned for evaluation.Visual and functional evaluations were performed.The balloon was inflated with approximately 20ml of water using an in-house syringe and was allowed to sit for 10 minutes.The balloon was massaged and no leaks were noted.The balloon was deflated without issue.The balloon appeared lopsided when inflated.; no further anomalies were noted with the balloon.The investigation is unconfirmed as the balloon was inflated with approximately 20ml of water using an in-house syringe and was allowed to sit for 10 minutes, the balloon was massaged and no leaks were noted.Additionally, the balloon was deflated without issue.Based upon the available information, the 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: h6 (result, conclusion).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.

• 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: 10687325
• Report Number: 3006260740-2020-20139
• Device Sequence Number: 16925104
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 000720
• Device Catalogue Number: 000720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/25/2020
• 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: 86 YR
• Patient Weight: 40