MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; FEEDING DEVICE

Model Number	000716
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was performed.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 03/2023).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 approximately fourteen days post feeding tube placement, during the replacement process, the medication injection port was allegedly leaking.There was no reported patient injury.
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 16 fr tri-funnel repl gastrostomy feeding tube was returned for evaluation.Visual, microscopic, tactile and functional testing were performed.The sample had evidence of staining and fluid residue and showed the product detailing on the device to be clear.Initial examination showed the internal retention balloon to inflate distendedly at first then evenly without leaking up to approximately 6 ml with the inflation port valve operating normally, even under slight manual manipulation of the balloon to and fro, with air, followed by water/fluid.Gross examination of the medicine port branch showed a surface outer skin puncture location marked with red at bd and a penetrative hole location marked with black at bd.The sample feeding tube and medicine port were separately patent to infusion and aspiration and leaking was observed from the black marked puncture hole on the medicine port branch.The investigation is confirmed for the alleged hole in the medicine tube and the leak that the hole causes.The definitive root cause could not be determined based upon available information.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: g4.H11: h3, h6 (results 1, conclusion 1).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 approximately fourteen days post feeding tube placement, during the replacement process, the medication injection port was allegedly leaking.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9648823
• Report Number: 3006260740-2020-00314
• Device Sequence Number: 2884690
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 000716
• Device Catalogue Number: 000716
• Device Lot Number: NGDS1541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1