MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARD LINTON INTRAGASTRIC TUBE, X-RAY OPAQUE; LINTON TUBE

Catalog Number	0092740
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 device allegedly,spontaneously dislodged from the patient.Upon removal, it was noted that the balloon was ruptured.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "warning: on tube, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause balloon to burst." (b)(4).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 device allegedly, spontaneously dislodged from the patient.Upon removal, it was noted that the balloon was ruptured.

• Brand Name: BARD LINTON INTRAGASTRIC TUBE, X-RAY OPAQUE
• Common Device Name: LINTON TUBE
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• MDR Report Key: 6507656
• Report Number: 1018233-2017-01937
• Device Sequence Number: 13753683
• Product Code: KNT
• UDI-Device Identifier: 00801741076848
• UDI-Public: (01)00801741076848
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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 Catalogue Number: 0092740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1