MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 18F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000718
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
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 provided, a review of the device history records is currently being performed.The device is pending return 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 leakage was observed next to the tube when inserting water.The leakage was better observed when pressing the balloon.There was no reported patient injury.
Event or Problem Description
It was reported that leakage was observed next to the tube when inserting water.The leakage was better observed when pressing the balloon.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was 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.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one 18 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 bond leak, as the gross visual observations in particular the balloon external membrane shows evidence of tearing apart from the core catheter with some material stress.The sample inflation tube was patent to infusion with the inflation port valve operating normally, and no leaks were observed at full inflation.However, pin hole type spray leaking was observed from the proximal end of the balloon membrane encasement under lower inflation and when the balloon was massaged back and forth.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported 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.(expiry date 09/2020).

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 18F
• 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: 7574741
• Report Number: 3006260740-2018-01252
• Device Sequence Number: 16195436
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: NGBS1439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 45