MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 18F; FEEDING DEVICE

Model Number	000718
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 01/2022).
Event or Problem Description
It was reported that within an hour of feeding device placement, the feeding tube allegedly dislodged out of the patient.It was further reported that upon inspection, the balloon was inflated and a pin hole sized leak was allegedly identified.Reportedly, the patient underwent anesthesia and another feeding tube was placed days later.The patient was stable at the conclusion of the procedure.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 18fr tri-funnel catheter was received for evaluation.A pinhole was noted on the balloon and a leak was observed upon inflation.The investigation is confirmed for the alleged pinhole.The ifu states to check the device prior to implantation.It is unknown if the pinhole was present upon opening of the device or if it was a result of handling.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or 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.H10: d4 (expiry date 01/2022); g4.H11: g1, h3, h6 (results, conclusion).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.
Event or Problem Description
It was reported that within an hour of feeding device placement, the feeding tube allegedly dislodged out of the patient.It was further reported that upon inspection, the balloon was inflated and a pin hole sized leak was allegedly identified.Reportedly, the patient underwent anesthesia and another feeding tube was placed days later.The patient was stable at the conclusion of the procedure.

• Brand Name: TRI-FUNNEL REPL GAST 18F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8647859
• Report Number: 3006260740-2019-01485
• Device Sequence Number: 16662293
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: NGCZ3541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization