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

Model Number	000287
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the procedure, bard button allegedly difficult to insert.It was further reported that button allegedly punctured.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.Device (expiry date: 04/2024).
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: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for the reported difficulty during insertion issue as the exact circumstances at the time of reported event cannot be verified and the clinical conditions cannot be replicated to confirm these failures.However, the investigation is confirmed for the reported obturator tears dome issue as the obturator was observed to be punctured and teared the dome was noted in the provided picture.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: (expiry date: 04/2024).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: device not returned.
Event or Problem Description
It was reported that prior to the procedure, bard button allegedly difficult to insert.It was further reported that button allegedly punctured.The procedure was completed using another device.There was no patient contact.
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 obturator handle inserted into a ponsky feeding device, one 60cc syringe, one sealed stoma measuring device package and an unsealed bard button replacement gastrostomy device were returned for evaluation.Gross visual and function testing were performed.In addition, one electronic photo was provided for review.The investigation is inconclusive for the reported difficulty during insertion issue as the exact circumstances at the time of reported event cannot be verified and the clinical conditions cannot be replicated to confirm these failures.However, the investigation is confirmed for the reported obturator tears dome issue as distal end of the obturator shaft was noted to be exposed from the device dome.The center of the feeding device dome was noted to split in half.A definitive root cause could not be determined based upon the provided 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: (expiry date: 04/2024).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.
Event or Problem Description
It was reported that prior to the procedure, bard button allegedly difficult to insert.It was further reported that button allegedly punctured.The procedure was completed using another device.There was no patient contact.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 24F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15444642
• Report Number: 3006260740-2022-03646
• Device Sequence Number: 20015940
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2023

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: 000287
• Device Catalogue Number: 000287
• Device Lot Number: HUFS1082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 05/04/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/05/2022; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 36 KG