MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 12F; REPLACEMENT G-TUBES

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional 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.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that the balloon ruptured.
Additional 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 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 was confirmed and the cause appears to be use related.The product returned for evaluation was an 12fr tri-funnel feeding tube.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through over-filling the feeding tube balloon.The appropriate inflation volume is listed on the inflation valve and over-inflation can be avoided by fully draining the balloon prior to inflation or re-inflation.The returned product sample was evaluated and a longitudinally-aligned split in the balloon membrane was observed.This catheter damage was determined to be typical of a burst, and the characteristics observed which supported this type of failure included: ¿ tensile weakness in the membrane at the fracture site (due to over-inflation prior to burst) ¿ granular fracture surface texture (typical of tearing failure modes) ¿ the split in the balloon was longitudinally aligned which is typical of burst-type failures, and the split traversed the entire length of the balloon.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.These features are characteristically found due to the over-inflation and fracture of the balloon tubing.The product instruction for use (ifu) contains the following information which may be relevant to this type of event, "do not exceed the maximum recommended inflation volume as this may cause excessive pressure on the gastric mucosa and migration of the internal balloon into the peritoneal cavity".
Event or Problem Description
It was reported that the balloon ruptured.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 12F
• Common Device Name: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6504552
• Report Number: 3006260740-2017-00443
• Device Sequence Number: 19152059
• Product Code: KNT
• UDI-Device Identifier: 00801741037115
• UDI-Public: (01)00801741037115
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1