MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® BAKER JEJUNOSTOMY CATHETER

Catalog Number	0042510
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.Udi format updated with available product information per gudid as requested 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.
Event or Problem Description
It was reported that the patient presented to the emergency department with a laceration in the jejunostomy catheter.The patient had been managing this tube at home, and the day before the tube was assessed to be intact.
Event or Problem Description
It was reported that the patient presented to the emergency department with a laceration in the jejunostomy catheter.The patient had been managing this tube at home, and the day before the tube was assessed to be intact.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions can be taken at this time since a root cause was not identified.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: sterile: unless package has been opened or damaged.Single use only.Do not reuse.Do not resterilize.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Note: after use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.Warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.The bard baker jejunostomy catheter with control vent is a biluminal plastic catheter size 16 fr.By 108 long or 12 fr.By 72 long.It has two opposing suction eyes, a 15cc (on 16 fr.Size) or 5cc (on 12 fr.Size) latex balloon and inflation lumen complete with valve.The control vent permits fingertip-controlled interruption of suction.Caution: test balloons for air leaks and proper inflation before using a tube.Udi format updated with available product information per gudid.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.

• Brand Name: BARD® BAKER JEJUNOSTOMY CATHETER
• Common Device Name: JEJUNOSTOMY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 20343757
• Report Number: 1018233-2024-06128
• Device Sequence Number: 8023903
• Product Code: KNT
• UDI-Device Identifier: 00801741075681
• UDI-Public: (01)00801741075681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 0042510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Unknown