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

Model Number	995081
Medical Device Problem Codes	Inflation Problem (1310); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
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.
Event or Problem Description
It was reported that there was a balloon malfunction in the bard x-force nephrostomy balloon dilation catheter.Per follow up information received via ibc on 23may2022, it was reported that the catheter balloon failed to inflate fully.It was stated that the fault occurred during use, but no patient injury was reported and the procedure was completed by using another bard x-force nephrostomy balloon dilation catheter.
Event or Problem Description
It was reported that there was a balloon malfunction in the bard x-force nephrostomy balloon dilation catheter.Per follow up information received via ibc on 23may2022, it was reported that the catheter balloon failed to inflate fully.It was stated that the fault occurred during use, but no patient injury was reported and the procedure was completed by using another bard x-force nephrostomy balloon dilation catheter.
Additional Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.The balloon dilation catheter was returned opened with the original packaging.No visible anomalies were noted on the returned device.Functional testing was performed by introducing a guidewire through the wire hub, using the balloon hub the catheter was filled with distilled water using an inflation device.The balloon was inflated and then it was pressurized to 15, 20, 25 and then 30 atm without show of any leaks or irregularities.The device was used for treatment purposes.The dhr review is not required, as the reported event is unconfirmed.As the reported event is unconfirmed, a label/packaging review is not required.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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14575910
• Report Number: 1018233-2022-04339
• Device Sequence Number: 5041479
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 02/01/2024
• Device Model Number: 995081
• Device Catalogue Number: 995081
• Device Lot Number: BMFUFM21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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