MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR, GW, MEDICON; FEEDING DEVICE

Model Number	006036
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was originally determined to be a malfunction reportable event on 07/15//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 was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that upon opening the feeding device kit, the tip of the guidewire was allegedly frayed.There was no patient contact.
Event or Problem Description
It was reported that upon opening the feeding device kit, the tip of the guidewire was allegedly frayed.There was no patient contact.
Additional 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 (b)(6) 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.Manufacturer review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one 0.038¿ od x 262.2 cm length ptfe coated guidewire was returned for evaluation.Visual, microscopic and dimensional testing were performed.The distal weld tip showed to be uncoiled and abrasion marks were noted throughout the length of the guidewire.The investigation is confirmed for the alleged frayed guidewire.Labeling review: the instructions for use (ifu) included in the product kit prescribed the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.The section instructions for device placement instructs to inspect contents of the kit for damage; it warns not to use if damaged.

• Brand Name: PEG SAFETY 20FR, GW, MEDICON
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9182540
• Report Number: 3006260740-2019-03019
• Device Sequence Number: 16837848
• Product Code: KNT
• UDI-Device Identifier: 00801741081194
• UDI-Public: (01)00801741081194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 006036
• Device Catalogue Number: 006036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1