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

Model Number 000720

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923); Migration (4003)

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

Event Date 09/18/2020

Event Type  malfunction  

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.The investigation of the reported event is currently underway.(expiry date: 08/2022).

Event Description

It was reported that approximately 15 days post feeding tube placement, the catheter allegedly dislodged.It was further reported that the catheter fell out of the patient.There was no reported patient injury.

Event Description

It was reported that approximately fifteen days post feeding tube placement, the catheter allegedly was dislodged.It was further reported that the catheter fell out of the patient.There was no reported patient injury.

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 20f was returned for evaluation.Gross, microscopic evaluation and functional testing were performed.The investigation is confirmed for tube dislodged, migration and balloon rupture issue as a rupture to the balloon was noted from the distal end of the device.The balloon was inflated with approximately 10ml of water and immediately deflated.A leak was observed from the rupture on the balloon.A definitive root cause could not be determined based upon the provided 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: 08/2022), g3.H11: section a through f ¿ the information provide by bd represents all 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: 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: 10784384
• MDR Text Key: 214553346
• Report Number: 3006260740-2020-20363
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

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
• Device Operator: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Device Lot Number: NGDW3857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other