MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® ALL-SILICONE FOLEY CATHETER

Model Number	806510
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer that ordered part 806510 through mckesson.The description in their catalogue stated catheter, foley silicone 5cc 10fr (12/cs) when the customer opened the box, the packages inside of it stated, they were 3cc.The lot on the case of catheters was nggw4222 and the lot number on the actual catheter was nggx3331.The customer was concerned that there might have been an error on bd¿s part when packaging this item, since the item stated it was a 5cc, but the reference number that match what they ordered and what was in the package stated it was a 3cc.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect bom".It is unknown whether the device had met relevant specifications.The product was used for treatment purpose.It was unknown whether the product had caused the reported failure.A dhr review is not required since is a mckesson incorrect classification of product.A labeling review was not performed because labeling could not have prevented the reported failure.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 device was not returned.
Event or Problem Description
It was reported that the customer that ordered part 806510 through mckesson.The description in their catalogue stated catheter, foley silicone 5cc 10fr (12/cs) when the customer opened the box, the packages inside of it stated, they were 3cc.The lot on the case of catheters was nggw4222, and the lot number on the actual catheter was nggx3331.The customer was concerned that there might have been an error on bd¿s part when packaging this item, since the item stated it was a 5cc, but the reference number that match what they ordered and what was in the package stated it was a 3cc.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY 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: 16520854
• Report Number: 1018233-2023-01618
• Device Sequence Number: 2316166
• Product Code: KOD
• UDI-Device Identifier: 00801741072918
• UDI-Public: (01)00801741072918
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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 Model Number: 806510
• Device Catalogue Number: 806510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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