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

Model Number	000716
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided, and a manufacturing review will be performed.The device has been returned for evaluation.The investigation is currently underway.(expiry date:03/2023).
Event or Problem Description
It was reported that post feeding device placement, there was allegedly a hole in one of the external components.It was further reported that the device was removed and replaced on the same day.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.Residue was noted throughout.A hole was noted on the joint of the medicine plug.No leaks were noted as the balloon was inflated, massaged, and deflated.The investigation is confirmed for the alleged hole in the lumen.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: g4 h11: 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 post feeding device placement, there was allegedly a hole in one of the external components.It was further reported that the device was removed and replaced on the same day.There was no reported patient injury.
Event or Problem Description
It was reported that post feeding device placement, there was allegedly a hole in one of the external components.It was further reported that the device was removed and replaced on the same day.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.Residue was noted throughout.A hole was noted on the joint of the medicine plug.No leaks were noted as the balloon was inflated, massaged, and deflated.The investigation is confirmed for the alleged hole in the lumen.The root cause of the failure was found to be manufacturing related.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:03/2023); g4.H11: h3, h4, 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.

• 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: 9516237
• Report Number: 3006260740-2019-04001
• Device Sequence Number: 1814508
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2020

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: 12/17/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 03/02/2020; 04/14/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/03/2020; 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1