MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON GASTROSTOMY TUBE, KIT, 18F; FEEDING DEVICE

Catalog Number 000283

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the reported 2 devices, lot numbers were provide for all the devices, and the lot history reviews are currently being performed.Of the 2 reported malfunctions, one device was returned to the manufacturer for evaluation and one device was not returned.Therefore, the investigation event is inconclusive for one malfunction.For the other malfunction the company is still investigating the issue at this time.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 000283 feeding device allegedly experienced disconnection.The information was received from various sources.Both the malfunctions involved patients with no patient consequences.For the reported two malfunctions age, weight and gender were not provided.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 000283 feeding device allegedly experienced disconnection.The information was received from various sources.Both the malfunctions involved patients with no patient consequences.For the reported two malfunctions age, weight and gender were not provided.

Manufacturer Narrative

H10: of the reported 2 devices, lot numbers were provide for all the devices, and the lot history reviews are currently being performed.Out of the two malfunctions, one device was returned for evaluation.The company is still investigating the issue at this time.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 Description

This report summarizes two malfunctions.A review of the reported information indicated that model 000283 feeding device allegedly experienced disconnection.The information was received from various sources.Both the malfunctions involved patients with no patient consequences.For the reported two malfunctions age, weight and gender were not provided.

Manufacturer Narrative

H10: the lot number for the two malfunctions was provided and a lot history review was performed.Out of the two reported malfunctions, the device was returned for one.Evaluation of the retuned device remains inconclusive for the alleged tube falling out.As the device was not returned, the reported leak and loose implant issue remains inconclusive for the other malfunction.Based upon the available information, the definitive root cause is unknown.The device are labeled for single use.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.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 18F
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10289432
• MDR Text Key: 199270360
• Report Number: 3006260740-2020-02525
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 000283
• Device Lot Number: HUDS1284
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1