MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000714
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 the catheter immediately came off after placement.It was confirmed that sterilized water leakage was found from the balloon when the balloon was inflated again and checked.There was no reported patient injury.
Event or Problem Description
It was reported that the catheter immediately came off after placement.It was confirmed that sterilized water leakage was found from the balloon when the balloon was inflated again and checked.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records (dhr) review is not available because the corporate lot number is unknown.Investigation summary: the sample returned for evaluation was one 14 fr tri-funnel replacement gastrostomy feeding tube.Visual, microscopic, and functional evaluations were performed of the physical sample.The sample is returned with a small pinhole leak emanating from the mid section of the balloon.Examination of the leak site revealed two superficial external surface damage slits, emanating from the outside inward which did not penetrate through the entirety of the wall, except for a resulting small hole in the balloon wall of one of the slits.The damage is indicative of sharp instrument contact but it could not be determined when/where that contact occurred, whether it was preexisting or occurred during/following insertion.This investigation is unconfirmed for deflation, cause unknown and confirmed for pinhole leak.The investigation indicates that the failure is resulting from pinhole leak, but the exact cause is unknown.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7936391
• Report Number: 3006260740-2018-02713
• Device Sequence Number: 1514571
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 000714
• Device Catalogue Number: 000714
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 01/27/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1