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

Catalog Number	996101
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
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.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 once the package was opened, the doctor found that the balloon pump was damaged on the balloon dilation catheter.The device was not used in the patient.It was stated that they replaced with a new balloon.Per additional information via email from ibc on 26sep2023, the balloon pump indicating balloon of the dilation cathter and the damage indicating ballon burst.
Event or Problem Description
It was reported that once the package was opened, the doctor found that the balloon pump was damaged on the balloon dilation catheter.The device was not used in the patient.It was stated that they replaced with a new balloon.Per additional information via email from ibc on 26sep2023, the balloon pump indicating balloon of the dilation cathter and the damage indicating ballon burst.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted the sample was received in a closed ziploc bag identified with a label with the customer complaint and additionally a biohazard label and sterilized by eo label.Inside of the bag there was the tyvek pouch with unit label identifying and lot number bmgxfm31, beside the tyvek pouch there was another ziploc bag with the balloon catheter and the stopcock attached.The balloon hub of the catheter reads " 10mm x 15 cm" and "30 atm" and the wire hub reads "0.038(0.97mm) wire." visual inspection was performed to the catheter, no damages were observed in the balloon, however it was identified that the balloon hub connector it was fully cracked.The stopcock was inspected and there are no signs of damages on it.The balloon hub was inspected under magnification and there are no visible marks of over torque in the hub connector, however, it was noticed that most of the cracks are exactly in the opposite director as the connector was crushed in those spots.Manufacturing process was reviewed and it was confirmed that there is no tolling that can crush the hub connector in the way it is seen in the sample received.Although an exact root cause could not be determined a potential root cause could be inappropriate package design.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "precaution: ¿ before use, inspect the device to verify that no damage has occurred during shipping and handling." 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® NEPHROSTOMY 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: 17894825
• Report Number: 1018233-2023-07261
• Device Sequence Number: 19696497
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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 Expiration Date: 02/08/2025
• Device Catalogue Number: 996101
• Device Lot Number: BMGXFM31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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