MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 24F G-TUBE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 000724

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 05/30/2017

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 ngas2057 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.

Event Description

The balloon was leaking during pre test with normal saline.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend 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 leaking balloon bolster was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 24fr tri-funnel replacement gastrostomy feeding device.The sample appeared free of obvious usage residues and the balloon bolster was positioned near the proximal end of the device.The balloon bolster was not inflated.An attempt to fill the balloon with water using a 12ml syringe revealed the balloon fill lumen to be patent; however, two circumferentially opposite leaks were observed in the balloon near the proximal end.Microscopic inspection of the leak sites revealed circumferentially opposite damage.The damage comprised circumferentially aligned splits.The split surfaces were sharply defined and coarsely striated.The splits in the balloon bolster exhibited characteristics consistent with damage caused by contact with a metallic grasping instrument such as forceps or hemostats.The relative positions of the splits indicated that the damage was caused by manipulation of the sample with such an instrument.The product ifu states ¿do not grasp the catheter with any instrument that might damage the catheter.¿.

Event Description

The balloon was leaking during pre test with normal saline.

• Brand Name: TRI FUNNEL 24F G-TUBE
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6656649
• MDR Text Key: 78246461
• Report Number: 3006260740-2017-00875
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177(17)180930(10)NGAS2057
• Combination Product (y/n): N
• Reporter Country Code: KE
• PMA/PMN Number: K910492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGAS2057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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: 35 YR
• Patient Weight: 58