MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F; FEEDING DEVICE

Model Number 000724

Device Problems Burst Container or Vessel (1074); Degraded (1153); Material Discolored (1170); Fluid/Blood Leak (1250); Migration (4003)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).

Event Description

It was reported that approximately two months post feeding tube placement, the tube allegedly busted and completely destroyed and what little was left was black in color.It was further reported that acid was allegedly leaking around the balloon and irritating the tract with pain.The patient current status is unknown.

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 tri-funnel replacement gastrostomy tube was returned for evaluation and four electronic photos were provided for review.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported balloon burst and fluid leak issue as a circumferential rupture was noted on the balloon.The edges of the circumferential rupture was noted to be jagged.Further, the investigation is also confirmed for the reported material discolored issue as the distal part of the balloon appeared black in color in the provided photo.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2023).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 Description

It was reported that approximately two months post feeding tube placement, the tube allegedly had a burst and completely destroyed and what little was left was black in color.It was further reported that acid was allegedly leaking around the balloon and irritating the tract with pain.The patient current status is unknown.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12602652
• MDR Text Key: 275891502
• Report Number: 3006260740-2021-04310
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGFP0978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other