MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F; FEEDING DEVICE

Model Number	000720
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 16f tri-funnel replacement gastrostomy tube were received for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified fracture issue as a longitudinal rupture was noted approximately 9mm from the end part of the device and appeared to be elongated circumferentially roughly midway.However, the investigation is inconclusive for the reported catheter dislodgement and migration, as the exact circumstances during the reported event were unknown.A definitive root cause could not be determined based upon the available information.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.
Event or Problem Description
It was reported that the catheter allegedly dislodged and fell out of the patient.The patient was reportedly stabilized.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F
• 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: 12548466
• Report Number: 3006260740-2021-04041
• Device Sequence Number: 17121918
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• 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
• Report Date (Section B): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000716
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/29/2021
• 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: Required Intervention