MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 18F; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 07/16/2017

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) of ngax1139 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (ngax1139) have been reported from the same (b)(6) facility.Device not yet returned for evaluation.

Event Description

It was reported that the gastrostomy probe was inserted on (b)(6)2017.On (b)(6)2017 balloon breakdown was noted.The device was withdrawal and provisorily passed a foley probe.Note: the device was with polihart connected to the proper route for infusion of medication and diet.No patient injury was reported.

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 ruptured balloon on a tri-funnel device was confirmed and determined to be use related.A 18fr tri-funnel replacement device was returned for investigation.The device revealed evidence of use.Residue was found within the feeding tube.Discoloration was observed in the balloon.A complete split was observed around the midpoint of the balloon.Due to the breach in the balloon material, the balloon could not be inflated.A microscopic examination of the split revealed that the adjoining surfaces of the balloon were granular.The observed damage is consistent with a burst due to over-pressurization.The product ifu indicates to not exceed the maximum recommended inflation volume.It is unknown if feeding or medication was administered into the color-coded balloon inflation lumen.Residue was found within the tube near the red inflation valve.The steps for checking the balloon volume are outlined in the ifu and the correct inflation volume was printed on the valve of the returned device.It appears that the tri-funnel replacement device was damaged during use.

Event Description

It was reported that the gastrostomy probe was inserted on (b)(6) 2017.On (b)(6) 2017 balloon breakdown was noted.The device was withdrawal and provisorily passed a foley probe.Note: the device was with polihart connected to the proper route for infusion of medication and diet.No patient injury was reported.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 18F
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6775436
• MDR Text Key: 82770636
• Report Number: 3006260740-2017-01252
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 000718
• Device Lot Number: NGAX1139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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
• Patient Age: 49 YR