MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD WIRE-GUIDED JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBE 9F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000732
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the j-tube was broken from the hub and coiled in the patient¿s stomach.The device was removed and a new device was placed.There was no reported patient injury.
Event or Problem Description
It was reported that the j-tube was broken from the hub and coiled in the patient¿s stomach.The device was removed and a new device was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a review of the dhr/manufacturing records cannot be conducted by bard access systems as this is a supplied component and those records are owned/maintained by the supplier.If an investigation of a returned sample provides evidence of a potentially manufacturing-related issue, then the supplier will be notified of the event and appropriate follow up will be conducted by the supplier quality team.If information is provided by the supplier, and is found relevant to the root cause of the reported event, such information will be added to this record at that time.Investigation summary: a dual port feeding adaptor and tubing from a jejunal feeding/gastric decompression push-tube kit was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for detached tubing from the y adaptor, as the tubing was found detached from the adapter.The proximal end of the of the tubing had an elliptical shaped cross-section.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.

• Brand Name: BARD WIRE-GUIDED JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBE 9F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7660190
• Report Number: 3006260740-2018-01600
• Device Sequence Number: 19119182
• Product Code: KNT
• UDI-Device Identifier: 00801741051661
• UDI-Public: (01)00801741051661
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 000732
• Device Catalogue Number: 000732
• Device Lot Number: ASAWF009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 56