MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD BUTTON GASTROSTOMY TUBE, KIT, 18F; FEEDING TUBE

Model Number	000282
Medical Device Problem Codes	Fluid/Blood Leak (1250); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 05/2023).
Event or Problem Description
It was reported during the procedure, the device was allegedly fluid leak.It was further reported the device allegedly had reflux within device.It was further reported another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one button replacement gastronomy tube was returned for evaluation.Functional and gross visual evaluation were performed.The investigation is inconclusive for the reported reflux with in the device as the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions and however clinical conditions cannot be replicated to confirm these failures.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.H10: d4 (expiry date: 05/2023).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 : see h10.
Event or Problem Description
It was reported during the procedure, the device was allegedly fluid leak.It was further reported the device allegedly had reflux within device.It was further reported another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 18F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11963945
• Report Number: 3006260740-2021-02229
• Device Sequence Number: 16942390
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 000282
• Device Catalogue Number: 000282
• Device Lot Number: HUES0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/22/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: 10 MO
• Patient Weight: 8