MAUDE Adverse Event Report: BARD INTERNATIONAL TRI FUNNEL 20F G-TUBE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	000702
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/02/2016
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 following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a black stain in the tubing of a ponsky device is confirmed.The sample returned was a segment of clear tubing.Visual observation found black patches within the lumen of the segment of tubing, which have the appearance of mold.The tubing was somewhat yellowish.Striations on each end of the segment were visible, and the edges were not ragged, but clean.The breaks appear to be due to intentional cutting.Mold and other accumulation of residues may be avoided by institutional maintenance protocols.For example, the patient care guide included with this product gives instructions regarding adding water in quantities prescribed by the md/hcp into the pump/feeding container when formula is almost finished.It also states that ¿flushing tubes with water before and after feedings will prevent most blockages.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the black stain was found in the catheter lumen.Although the catheter was washed by rubbing with a brush, the stain was not removed.During placement, the used medicines were as followed; lansoprazole, furosemide, clarithromycin, spironolactone, itopride, carbocisteine, rhubarb, liquorices root, sodium chloride, nauzelin dry syrup, and pantethine acid.On (b)(6) 2017-evaluation noted stain has appearance of mold.Conservatively reported.

• Brand Name: TRI FUNNEL 20F G-TUBE
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARD INTERNATIONAL; d/s account; 111 spring street; murray hill NJ 07974
• MDR Report Key: 6836601
• Report Number: 3006260740-2017-01496
• Device Sequence Number: 800244
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: 000702
• Device Catalogue Number: 000702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1