MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 12F G-TUBE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	000712
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of ngzk4425 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (ngzk4425) have been reported from the same facility.Device not returned yet.
Event or Problem Description
It was reported that one day after the probe installation, it presented a leak.The cuff was tested before use with 3 ml of distilled water.It was necessary to change the product.The patient was already using the probe previously.The probe was passed in an outpatient procedure, with use of nan diet (infant formula).This file addresses sample #1.
Additional Manufacturer Narrative
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 leak is confirmed and was determined to be manufacturing related.One 12 fr tri-funnel feeding catheter was returned for evaluation.An initial visual observation showed use residue throughout the sample.Tensile weakness was observed approximately 1 cm distal to the end of the taper of the hub.The sample was pressurized with water and a small, spraying leak was observed approximately 1 cm distal to the end of the taper of the hub.A microscopic observation revealed a small ¿s¿-shaped split in the catheter.The edges of the split were observed to be well-defined but irregular and the surface texture of the split was observed to be mostly granular in texture.Indentations were observed in the catheter material opposite the split.A lot history review (lhr) of ngzk4425 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (ngzk4425) have been reported from the same facility.
Event or Problem Description
It was reported that one day after the probe installation, it presented a leak.The cuff was tested before use with 3 ml of distilled water.It was necessary to change the product.The patient was already using the probe previously.The probe was passed in an outpatient procedure, with use of nan diet (infant formula).This file addresses sample #1.

• Brand Name: TRI FUNNEL 12F G-TUBE
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6919346
• Report Number: 3006260740-2017-01780
• Device Sequence Number: 16368421
• Product Code: KNT
• UDI-Device Identifier: 00801741037115
• UDI-Public: (01)00801741037115
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: 000712
• Device Catalogue Number: 000712
• Device Lot Number: NGZK4425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO