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

Model Number 000720

Device Problem Hole In Material (1293)

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

Event Date 05/01/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.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 that a pinhole was detected in the balloon during a pretest.

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 leaking from the balloon was confirmed as manufacturing related.One 20fr tri-funnel replacement device was returned for investigation.The balloon was not inflated.Residue was observed within the feeding tube.A microscopic examination revealed that the white plug was not located within the distal end of the inflation lumen.An attempt was made to inflate tri-funnel balloon with water, but the infused liquid bypassed the balloon and exited from the distal end of the device.The complaint sample was forwarded to the manufacturing facility for further review.The current process controls were reviewed and the personnel involved in the manufacturing process were notified and retrained.

Event Description

It was reported that a pinhole was detected in the balloon during a pretest.

• 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: 6589789
• MDR Text Key: 76043049
• Report Number: 3006260740-2017-00685
• 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: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/19/2017
• 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