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

Model Number 000702

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

It was reported that post gastrostomy feeding tube placement procedure, the connection of the cap was allegedly broken.It was further reported that the device was removed.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one ponsky dual port feeding tube adapter was received for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture and identified material separation issue as a complete break was noted on the closure strap segment.The surface was noted to be granular.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.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 post gastrostomy feeding tube placement procedure, the connection of the cap was allegedly broken.It was further reported that the device was removed.There was no reported patient injury.

• Brand Name: PONSKY 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
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16031420
• MDR Text Key: 306281155
• Report Number: 3006260740-2022-05801
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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