MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® BALLOON DILATION CATHETER

Catalog Number	998006
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no pressure was applied from the beginning due to faulty connection between meter and syringe.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 no pressure was applied from the beginning due to faulty connection between meter and syringe.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted one inflation device was returned to atrion inside a plastic bag.Upon receipt of the complaint device a visual inspection was conducted.During the visual inspection, it was noted that the gauge was broken from the inflation device housings at the glue plug area.The device also exhibited an unknown crystalized substance.The needle on the gauge was also noted to be within the zero position.However, functional testing could not be performed on the inflation device due to the gauge being detached from the inflation device body.Devices that pass this test are marked by automation for identification.Devices that fail are not marked.The returned device was marked, indicating it met pressure integrity when it left our facility.It was also noted 2 photo samples were received.First photo sample shows top view of eagle inflation device on side.Second photo zooms in on gauge disconnected from inflation device.Based on photo and physical samples received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be uv bond of the glue plug of the complaint device may not have been fully cured.A dhr review is not required as no lot number was reported for this investigation.The instructions for use were found adequate and state the following: "preparation of the catheter: 1.Carefully inspect the catheter for signs of damage.Do not use the product if damage is evident." 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 actual/suspected device was inspected.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17633781
• Report Number: 1018233-2023-06401
• Device Sequence Number: 6339734
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• 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): 12/21/2023

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: 998006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown