MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; FEEDING DEVICE

Model Number	000716
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
It was reported that, approximately five years post use, the balloon allegedly ruptured on a feeding device.It was further reported that the balloon rupture was identified after the feeding catheter existed through the stoma.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: dhr review for corporate lot no.Ngbs0071 of product 000716 used in the manufacturing of this lot did not show any rejects for certain qa random visual inspection; no rejects were reported for the reported issue.Various inspections were reported for various components/subassemblies where no rejects were recorded.Investigation summary: one 16 fr tri-funnel repl gastrostomy feeding tube was returned for evaluation.Visual, microscopic, tactile, and functional evaluations were performed.The investigation is confirmed for balloon deflation, more specifically, a balloon burst.The device manifested a rupture in the balloon, partially circumferential, with evidence of tearing with sharp edges and a relatively rough grained break surface.Stretched balloon material was discolored.Infusion through the inflation port was more difficult than normal and resulted in a leak at the burst.The complaint of a balloon rupture is confirmed, and while a definitive root cause could not be determined based upon available information, procedural issues such as overinflation or balloon damage may have contributed to this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that, approximately five years post use, the balloon allegedly ruptured on a feeding device.It was further reported that the balloon rupture was identified after the feeding catheter existed through the stoma.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7929130
• Report Number: 3006260740-2018-02692
• Device Sequence Number: 1449002
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 000716
• Device Catalogue Number: 000716
• Device Lot Number: NGBS0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INDUSTRIALIZED DIET TROFIC BASIC 1,5; INDUSTRIALIZED DIET TROFIC BASIC 1,5; INDUSTRIALIZED DIET TROFIC BASIC 1,5
• Patient Age: 89 YR
• Patient Weight: 70