MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 22F; FEEDING TUBE

Model Number 000722

Device Problems Disconnection (1171); Fracture (1260); Device Dislodged or Dislocated (2923)

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

Event Date 05/24/2021

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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that sometimes post feeding device placement, the probe allegedly disconnected.It was further reported that the cuff allegedly broken.There was no reported patient injury.

Manufacturer Narrative

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 22f with peel-apart sheath handle that appeared to be two halves were received for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.One electronic photo were provided for evaluation.The investigation is confirmed for the reported fracture issue as a longitudinal rupture was noted on the proximal end of the balloon and the surface around the rupture appeared to be jagged and the photo also confirms the same.However, the investigation is inconclusive for the reported device dislodgement as the exact circumstances during the reported event were unknown.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.D4 (expiry date: 05/2023).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.

Event Description

It was reported that sometimes post feeding device placement, the probe allegedly dislodged.It was further reported that the cuff allegedly broken.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 22F
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12236909
• MDR Text Key: 264968130
• Report Number: 3006260740-2021-02964
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037160
• UDI-Public: (01)00801741037160
• 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: 08/20/2021

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: 000722
• Device Catalogue Number: 000722
• Device Lot Number: NGDW1637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other