MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; INTERMITTENT CATHETER

Model Number	010116
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
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 customer got 3 boxes of 12 intermittent catheters that were defective all the same lot.Customer stated that the end of them was curl over and were very hard.Customer also mentioned that up at the top they were shorter in the packaging, 2 inch shorter than usual.Up at the top of the catheter, the outlet part there were a large bump on it.So, insertion would be difficult because of the hard curl end.Customer request replacement for the defective product.Per follow up via pone 08jun2023, customer stated that they did not use the catheters, they saw the defect before use and wanted to inform the company of the affected lots.
Event or Problem Description
It was reported that customer got 3 boxes of 12 intermittent catheters that were defective all the same lot.Customer stated that the end of them was curl over and were very hard.Customer also mentioned that up at the top they were shorter in the packaging, 2 inch shorter than usual.Up at the top of the catheter, the outlet part there were a large bump on it.So, insertion would be difficult because of the hard curl end.Customer request replacement for the defective product.Per follow up via pone (b)(6) 2023, customer stated that they did not use the catheters, they saw the defect before use and wanted to inform the company of the affected lots.Per notification from investigator on 31jul2023, during sample evaluation it was found that the scratch found on the shaft close to the funnel of intermittent catheter.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: INTERMITTENT 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: 17164811
• Report Number: 1018233-2023-04522
• Device Sequence Number: 12198512
• Product Code: KOD
• UDI-Device Identifier: 00801741029875
• UDI-Public: (01)00801741029875
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: 010116
• Device Catalogue Number: 010116
• Device Lot Number: NGFR3276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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