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
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 one.

• Brand Name: BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F
• Common Device Name: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6970580
• Report Number: 3006260740-2017-01882
• Device Sequence Number: 1156296
• Product Code: KGC
• UDI-Device Identifier: 00801741080821
• UDI-Public: (01)00801741080821
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

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: N/A
• Device Catalogue Number: 000256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1