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

Model Number 995101

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the wrong intended for use (ifu) was attached in the balloon dilation catheter package.

Manufacturer Narrative

The reported event is confirmed as distributor related.No physical sample was returned, however, a photo sample was submitted.The photo sample shows the incorrect ifu for the product attached.Per the non-conformance report received, the incorrect ifu was attached to the product at the local distributor facility."specific operator is not assigned for ifu picking process because there is no process to assign the operator for ifu picking.Therefore, human error occurred for wrong labeling issue." based on this information, the root cause for this event would be human error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bard represents all of 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 bard.

Event Description

It was reported that wrong ifu was attached in the balloon dilation catheter package.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: QQQDILATION 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: 12760431
• MDR Text Key: 284881972
• Report Number: 1018233-2021-06981
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00801741080722
• UDI-Public: (01)00801741080722
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: 995101
• Device Catalogue Number: 995101
• Device Lot Number: BMFNFM46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other