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

Model Number	000282
Medical Device Problem Codes	Fracture (1260); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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 has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 02/2021).
Event or Problem Description
It was reported that some time post gastrostomy feeding tube placement, the button allegedly broke.It was further reported that the device allegedly had a fitting problem.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 18fr feeding button was returned for evaluation.Gross visual evaluation was performed.The investigation is confirmed for the reported fracture issue and inconclusive for the reported fitting problem, as the plug of the closure strap was missing.The 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: 02/2021), g3, h6 (method).H11: b5, h6 (result, conclusion).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.H3 other text : see h10.
Event or Problem Description
It was reported that the during a gastrostomy feeding tube placement, the button allegedly broke.It was further reported that the device allegedly had a fitting problem.There was no reported patient injury.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE, 18F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12712322
• Report Number: 3006260740-2021-04607
• Device Sequence Number: 14628665
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: HUCP1759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male