MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM; TUBE, GASTRO-ENTEROSTOMY

Model Number	000282
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.Device not returned at this time.
Event or Problem Description
It was reported that the cap broke off the gastrostomy device.The device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information was received from the complainant on 07/30/2018 and the associated fields were updated.Photos were provided and are being evaluated.The investigation is currently underway.No medical records or medical images have been made available to the manufacturer.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.
Event or Problem Description
It was reported that the cap broke off the gastrostomy device.The device was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that the cap broke off the gastrostomy device.The device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review:the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one 18 fr x 1.7cm button was returned for evaluation and three photos were provided for review.In the visual inspection and photo review, it was noted that the cap was not attached to the strap.The cap was not returned with the sample.When viewed under magnification, the break surface on the strap was noted to possess parallel striations.Based on the findings, the investigation is confirmed for the reported cap detachment.Per the evaluation results, the break surface had two sets of parallel striations, propagating in a semi-circular path from either side of the break.This is typical of a break due to sharp instrument damage.Therefore, it is possible that a cut with a sharp instrument contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Other potential contributing factors include material fatigue and stress on the cap.Labeling review:the instructions for use (ifu) included in the product kit prescribed the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7701271
• Report Number: 3006260740-2018-01758
• Device Sequence Number: 11022884
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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: HUBU0431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/30/2018; 02/12/2019
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/17/2018; 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 25