MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F; FEEDING DEVICE

Model Number 000720

Device Problems Migration (4003); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be 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.

Event Description

It was reported that some time post feeding device placement, the device allegedly exteriorized.It was further reported that the cuff was found to be torn.There was no reported patient injury.

Event Description

It was reported that some time post feeding device placement, the device allegedly exteriorized.It was further reported that the cuff was found to be torn.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned to the manufacturer for evaluation.One electronic photo was provided for review.Tear in the balloon/internal bolster can be seen in the provided photo.Therefore, the investigation is confirmed for the reported material torn and the investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event are unknown.Based upon the available information, the definitive root cause for this event is unknown.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.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.H3 other text : device not returned.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F
• 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: 12114741
• MDR Text Key: 260018219
• Report Number: 3006260740-2021-02590
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other