MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 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 Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that approximately two months post gastrostomy tube placement, the feeding tube balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that approximately one month post gastrostomy tube placement, the feeding tube balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was not returned for evaluation.Therefore, the reported balloon rupture cannot be confirmed.A definitive root cause could not be determined based upon 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.H10: d4(expiry date: 03/2023),g4 h11: b5,d4(corporate lot number),d6,h6(method) 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.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10476208
• Report Number: 3006260740-2020-03093
• Device Sequence Number: 2391070
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: NGDU1295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1