MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F; FEEDING AND DECOMPRESSION TUBES

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.The initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the formula turned black was confirmed, and the cause appeared to be related to use.Two button continuous feeding tubes with 90-degree adaptor were returned for investigation.Evidence of use was observed on each feeding tube.A dark colored sticky residue was found within the feeding tubes and on the external surface of the tubes.Residue was flushed from each tube.The sticker with the product label had been removed from each tube.The residue and discoloration indicate that the product was used and may be attributable to mold, yeast, and/or bacteria that can migrate from the stomach or the formula into the feeding tube.The microorganisms attach to the walls of the feeding tube and grow, leading to tube clogging and degradation.It is unknown if the continuous feeding tubes were flushed with water after feeding was complete, mechanically cleaned with soap and warm water, and thoroughly rinsed after each use as instructed in the ifu.No defects related to the manufacturing process were noted on the complaint sample.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Per sales rep, the facility reported that the tubing turned black while formula was infusing to the g-tube.The tubing was replaced.This report addresses tubing two.

• Brand Name: BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F
• Type of Device: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6970576
• MDR Text Key: 90779506
• Report Number: 3006260740-2017-01883
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741080821
• UDI-Public: (01)00801741080821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1