MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 12F TETHER J-TUBE; FEEDING DEVICE

Model Number	000733
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was originally determined to be a malfunction reportable event on 08/07//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.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that some time post placement of the jejunal (j) tube through the percutaneous endoscopic gastrostomy (peg) tube, the patient allegedly experienced abdominal distension and the jejunal tube was pushed four inches away from the stomach.Reportedly, the device was removed and replaced.During the device removal procedure, it was found that the jejunal tube was intertwined with the percutaneous endoscopic gastrostomy tube.There was no reported patient injury.

• Brand Name: 12F TETHER J-TUBE
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9182549
• Report Number: 3006260740-2019-03016
• Device Sequence Number: 11411093
• Product Code: KNT
• UDI-Device Identifier: 00801741051678
• UDI-Public: (01)00801741051678
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K946249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 000733
• Device Catalogue Number: 000733
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1