MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 18F; FEEDING DEVICE

Model Number 000718

Device Problems Burst Container or Vessel (1074); Disconnection (1171); Fluid/Blood Leak (1250); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Extravasation (1842)

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).

Event Description

It was reported that post device placement, the feeding tube allegedly came out of the device.It was further reported that the balloon was ruptured and extravasation was noted.The current status of the patient is unknown.

Event Description

It was reported that ten days post device placement, the feeding tube allegedly came out of the device.It was further reported that the balloon was ruptured and extravasation was noted.The current status of the patient 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: the physical device was not returned for evaluation.Three electronic photo were provided for review.The investigation is confirmed for the reported fracture as a longitudinal rupture in the balloon of the device was noted on all the provided photos.However, the investigation is inconclusive for the reported device dislodgement and fluid leak as the exact circumstances during the reported event were unknown.The definitive root cause could not be determined based upon 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: b5, d4 (expiry date: 04/2023), g3 h11: h6 (device, method, 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.Device not returned.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 18F
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12178985
• MDR Text Key: 261900116
• Report Number: 3006260740-2021-02763
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (y/n): N
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: NGDV2559
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other