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

Model Number	000286
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.Medical device expiry date: 09/2022.
Event or Problem Description
It was reported that post replacement of the tube, the device allegedly leaked around the button.It was further reported that the patient had inflammation of the abdomen and infection.The patient's current status was unknown.
Event or Problem Description
It was reported that post replacement of the tube, the device allegedly leaked around the button.It was further reported that the patient had inflammation of the abdomen and infection.The patient's current status was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the investigation is inconclusive for the reported leakage around the button issue, as the device was not returned for evaluation.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: 09/2022), g3.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 BUTTON GASTROSTOMY TUBE, KIT, 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: 11420453
• Report Number: 3006260740-2021-00619
• Device Sequence Number: 3976511
• Product Code: KGC
• UDI-Device Identifier: 10801741087896
• UDI-Public: (01)10801741087896
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 000286
• Device Catalogue Number: 000286
• Device Lot Number: HUDX1810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/05/2021
• 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