MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD LINTON INTRAGASTRIC TUBE

Model Number	0092740
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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 device was not returned.
Event or Problem Description
It was reported that the linton tube was inserted into the patient and inflated as per the protocol.It was stated that the user confirmed on x-ray, that the balloon had completely deflated and did not occlude the blood flow.Upon removal, it was noted that there was a hole in the balloon.
Event or Problem Description
It was reported that the linton tube was inserted into the patient and inflated as per the protocol.It was stated that the user confirmed on x-ray, that the balloon had completely deflated and did not occlude the blood flow.Upon removal, it was noted that there was a hole in the balloon.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿¿exposure to petroleum based products , over exposure to ozone resulting in product degradation¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be completed due to lot number not provided.Therefore, no additional action is required at this time.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 were found adequate and state the following: caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Warning: on tube, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause balloon to burst.Storage: store at room temperature away from direct exposure to light, preferably in the original package.Sterilization: if sterile use is desired, the tube may be sterilized by ethylene oxide or steam autoclave.Warning: remove plastic plugs prior to sterilization.Typical conditions for ethylene oxide sterilization are 500 mg/l ethylene oxide, 30-70% relative humidity, and 120-130°f.Exposure times will vary depending on the type of equipment used.The equipment manufacturer¿s recommendations should be followed along with the proper use of biological controls.Aeration cycles for the removal of ethylene oxide residues should be carried out according to the equipment manufacturer¿s instructions.Typical conditions for steam sterilization are 20 minutes at 250°f or 5 minutes at 270°f.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

• Brand Name: BARD LINTON INTRAGASTRIC TUBE
• Common Device Name: LINTON INTRAGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12253345
• Report Number: 1018233-2021-04643
• Device Sequence Number: 4950600
• Product Code: KNT
• UDI-Device Identifier: 00801741076848
• UDI-Public: (01)00801741076848
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 0092740
• Device Catalogue Number: 0092740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: Other