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

Catalog Number	010114
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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 the patient frequently received red rubber urethral catheters in which the orientation bump was off to one side.With enough manipulation they could usually make it work, but they thought the bump should always be in line with the coude tip.Representative agreed with patient.They had no product or lot or samples available, also advised that next time if they received a shipment with this issue to hold onto the packaging and the product for investigation.Per follow up via phone on (b)(6) 2023.It was reported that the red rubber coude catheters were not lining up.They had samples.Also provided lot numbers.Nghq0271 and nggy2332.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Visual evaluation of the returned eleven samples noted eleven opened (with original packaging), urological catheter.Visual inspection of the eleven samples noted the bump aligned with the catheter tip.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.The reported event is unconfirmed a labeling 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.
Event or Problem Description
It was reported that the patient frequently received red rubber urethral catheters in which the orientation bump was off to one side.With enough manipulation they could usually make it work, but they thought the bump should always be in line with the coude tip.Representative agreed with patient.They had no product or lot or samples available, also advised that next time if they received a shipment with this issue to hold onto the packaging and the product for investigation.Per follow up via phone on 05sep2023, it was reported that the red rubber coude catheters were not lining up.They had samples.Also provided lot numbers nghq0271 and nggy2332.
Event or Problem Description
It was reported that the patient frequently received red rubber urethral catheters in which the orientation bump was off to one side.With enough manipulation they could usually make it work, but they thought the bump should always be in line with the coude tip.Representative agreed with patient.They had no product or lot or samples available, also advised that next time if they received a shipment with this issue to hold onto the packaging and the product for investigation.Per follow up via phone on (b)(6) 2023, it was reported that the red rubber coude catheters were not lining up.They had samples.Also provided lot numbers.Nghq0271 and nggy2332.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "machine error".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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.

• 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: 17819742
• Report Number: 1018233-2023-07082
• Device Sequence Number: 19408798
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2024

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 Catalogue Number: 010114
• Device Lot Number: NGHQ0271
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/12/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/14/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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