MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD JEJUNAL FEEDING/DECOMPRESSION TUBE; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asauf001 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 12/21/2016- per medwatch report, the facility reported, "jejunostomy feeding tube was being inserted through an existing gastrostomy tube via endoscopy.Patient had tumor burden at the gastric outlet and tube was difficult to place.The guidewire became tangled around the distal end of the tube.Attempts to withdraw the tube via endoscopy were unsuccessful.Patient transferred to interventional radiology for tube extraction.They successfully withdrew the tube and guidewire, but distal end of the tube,with the weight ,sheered off and remained lodged in the gastric outlet.Patient transferred back to gi lab and distal weighted tube end was removed by endoscopy".

• Brand Name: BARD JEJUNAL FEEDING/DECOMPRESSION TUBE
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6238913
• Report Number: 3006260740-2016-00716
• Device Sequence Number: 10854711
• Product Code: KNT
• UDI-Device Identifier: 00801741051678
• UDI-Public: (01)00801741051678(17)190703(10)ASAUF001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K946249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2016
• Report Date (Section F): 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2019
• Device Model Number: N/A
• Device Catalogue Number: 000733
• Device Lot Number: ASAUF001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/18/2016