MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 20F G-TUBE; REPLACEMENT G-TUBES

Catalog Number 000720

Device Problem Inflation Problem (1310)

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

Event Date 03/28/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the facility that after placing the catheter through the gastrostomy opening the funnel inflated, but not the the balloon.No reported patient harm.

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 difficulty inflating the feeding tube was confirmed and the cause was manufacturing related.The product returned for evaluation was a 20fr tri-funnel feeding tube.The device contained little evidence of use with no usage residue observed and no discoloration.Gross visual evaluation of the device found that the feeding canal was completely occluded with what appeared to be clear manufacturing silicone or adhesive.An attempt was made to inflate the feeding tube balloon and the device would not inflate.Blue colored water was used in an attempt to locate the blockage point and the water would not advance past the tri-funnel taper.The device was then cut, at bard, near the tapered region and a thin wire was fed into the inflation conduit and the wire was found to advance into the balloon however, inflation was still not possible.It was determined that the excess manufacturing material which occluded the feeding canal also prohibited the balloon from properly inflating.

Event Description

It was reported by the facility that after placing the catheter through the gastrostomy opening the funnel inflated, but not the balloon.No reported patient harm.

• Brand Name: TRI FUNNEL 20F G-TUBE
• Type of Device: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: michael new ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225445
• MDR Report Key: 6501622
• MDR Text Key: 73256783
• Report Number: 3006260740-2017-00426
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2017
• 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