MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR GASTROSTOMY TUBE 20F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000702
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.Device not returned at this time.
Event or Problem Description
It was reported that nutrition leaked out from the fistula.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the dhr review is not available because the corporate lot number is unknown.Investigation summary: one ponsky non-balloon repl (nbr) gastrostomy feeding tube was returned for evaluation.Visual, microscopic, and functional evaluations were performed.The investigation is inconclusive for subcutaneous leak/break/split without embolism, as the device was received with the catheter split between the 13th and 14th depth marker.A split was observed between the 4th and 5th depth marker, hidden underneath the support wings.The split propagated approximately circumferential around the catheter.However, due to the component being returned on its own upon return it is unknown whether the catheter breaks could have been happened in clinical/manufacturing/packaging return procedure.The definitive root cause could not be determined based upon available information.It is unknown if clinical/manufacturing/shipping procedures issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that nutrition leaked out from the fistula.There was no reported patient injury.

• Brand Name: PONSKY NBR GASTROSTOMY TUBE 20F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7679950
• Report Number: 3006260740-2018-01693
• Device Sequence Number: 11151376
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1