MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F; FEEDING

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	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (03/2023).
Event or Problem Description
It was reported that post feeding device placement, the medication injection was allegedly leaked.It was further reported that there is a little hole in the luer connection.It was further reported that a another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review is required.Investigation summary: one tri-funnel replacement gastrostomy tube 16f was received and evaluated.A hole between the luer and catheter was noted on the proximal end of the device.A hole was noted between the catheter and the feeding tube.The catheter was infused with approximately 10ml of water through the injection port.A leak was noted at the hole between the catheter and the feeding tube.The investigation is confirmed for the alleged hole and leaking of the feeding tube.The suspected root cause is manufacturing root cause.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: h6 (methods, result,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, the medication injection was allegedly leaked.Reportedly, there is a little hole in the luer connection.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F
• Common Device Name: FEEDING
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10182796
• Report Number: 3006260740-2020-02182
• Device Sequence Number: 835315
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 06/22/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1