MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY PEG WITH DELUXE KIT, 20F; FEEDING DEVICE

Model Number	000793
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2020
Type of Reportable Event	Malfunction
Additional 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 not been returned to the manufacturer for evaluation, however images have been provided.The investigation of the reported event is currently underway.(expiry date: 09/2020).
Event or Problem Description
It was reported during insertion of percutaneous endoscopic gastrostomy, the tip of the device was allegedly split.It was further reported that the device was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, two medical images were provided for review.The investigation is confirmed for the reported fracture issue, as the images shows a ponsky peg tube with a split noted at the distal end.A definitive root cause could not be determined based upon available information.Labeling review: h10: d4 (expiry date: 09/2020),g4.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 or Problem Description
It was reported during insertion of percutaneous endoscopic gastrostomy, the tip of the device was allegedly split.It was further reported that the device was removed.There was no reported patient injury.

• Brand Name: PONSKY PEG WITH DELUXE KIT, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10228960
• Report Number: 3006260740-2020-02319
• Device Sequence Number: 3092973
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 000793
• Device Catalogue Number: 000793
• Device Lot Number: HUDV1668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 68