MAUDE Adverse Event Report: BARD ACCESS SYSTEMS CONTINUOUS FEEDING TUBE 24F; FEEDING AND DECOMPRESSION TUBES

Model Number	000258
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 hubt1737 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that when the package was opened they alleged a possible issue with the product molding; they noticed what appeared to look like a pin hole by the "bell shape" on the tube.Device was not used on patient.

• Brand Name: CONTINUOUS FEEDING TUBE 24F
• Common Device Name: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6956478
• Report Number: 3006260740-2017-01839
• Device Sequence Number: 13639448
• Product Code: KGC
• UDI-Device Identifier: 00801741080845
• UDI-Public: (01)00801741080845
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2017

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: 000258
• Device Catalogue Number: 000258
• Device Lot Number: HUBT1737
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR