MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONKSY MBR 20 FR; FEEDING DEVICE

Model Number 000700

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was originally determined to be a malfunction reportable event on (b)(6)2019 and reported to the fda through the quarterly voluntary malfunction summary reporting (vmsr) program.Bdpi received a notification from the fda on 9/16/2019 stating that the procode knt is ineligible for the vmsr program; therefore, the mdr date of awareness was modified to reflect the date of the fda notification of procode ineligibility.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 10/2021).

Event Description

It was reported that the obturator was allegedly missing from the kit.There was no patient involvement.

Event Description

It was reported that the obturator was allegedly missing from the kit.There was no patient involvement.

Manufacturer Narrative

The complaint was originally determined to be a malfunction reportable event on 9/4/2019 and reported to the fda through the quarterly voluntary malfunction summary reporting (vmsr) program.Bdpi received a notification from the fda on 9/16/2019 stating that the procode knt is ineligible for the vmsr program; therefore, the mdr date of awareness was modified to reflect the date of the fda notification of procode ineligibility.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 ponsky non-balloon gastrostomy tube, one external bolster, one curved hemostat, 2 gauze strips, one packet of lubricating jelly, and one dual port feeding adapte.Visual testing was performed.The obturator was not returned.However, due to the fact that the kit was returned opened and all its components out, the investigation is inconclusive for the alleged missing obturator.A definitive root cause could not be determined based on the available information.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.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.

• Brand Name: PONKSY MBR 20 FR
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9182624
• MDR Text Key: 164435552
• Report Number: 3006260740-2019-03020
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741036286
• UDI-Public: (01)00801741036286
• Combination Product (y/n): N
• PMA/PMN Number: K103109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000700
• Device Catalogue Number: 000700
• Device Lot Number: REDQ1594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1