TRI-FUNNEL FEEDING DEVICE

Description of Event or Problem

IT WAS REPORTED THE BALLOON OF A GASTROSTOMY TUBE ALLEGEDLY RUPTURED AND DID NOT HOLD INFLATION DURING A SPAN OF APPROXIMATELY SEVEN TO TEN DAYS. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

MANUFACTURING REVIEW: THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED BALLOON DEFLATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE BALLOON. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE OVER-INFLATION AND VALVE DAMAGE; HOWEVER, THE LACK OF A RETURNED SAMPLE PREVENTED BOTH CONFIRMATION OF THE REPORTED EVENT AND IDENTIFICATION OF A ROOT CAUSE(S). 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. (EXPIRY DATE: 09/2020), (MANUFACTURING DATE: 03/2018).

Description of Event or Problem

IT WAS REPORTED THE BALLOON OF A GASTROSTOMY TUBE ALLEGEDLY RUPTURED AND DID NOT HOLD INFLATION DURING A SPAN OF APPROXIMATELY SEVEN TO TEN DAYS. THERE WAS NO REPORTED PATIENT INJURY.