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

Model Number	010114
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
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 customer received the intermittent catheters were twisted and unlevel.Stated that the customer suspect the issue occurred during packaging.Per additional information received via form with sample returned on (b)(6)2022 , customer stated that catheters were in individual packaging, all twisted.Also stated that for $20 per catheter, they would think that they could get one that was not so twisted.Customer thought catheter were twisted when the workers were jamming them into packages and poor-quality control.Per notification from investigator on (b)(6)2022 , during sample evaluation it was found that the coude tip and indicator notch were found to be misaligned.
Event or Problem Description
It was reported that customer received the intermittent catheters were twisted and unlevel.Stated that the customer suspect the issue occurred during packaging.Per additional information received via form with sample returned on 05jul2022, customer stated that catheters were in individual packaging, all twisted.Also stated that for (b)(6)per catheter, they would think that they could get one that was not so twisted.Customer thought catheter were twisted when the workers were jamming them into packages and poor-quality control.Per notification from investigator on 07oct2022, during sample evaluation, it was found that the coude tip and indicator notch were found to be misaligned.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.14 tiemann coude catheters were returned unopened.No visual defects were noted on the surface of the catheters.The coude tips had some curve.Sample meets specification "accept any curve unless catheter is completely straight".The eyes were not noted to have any flashing.The catheters were labelled 1-14 for identification.The coude tips were aligned with the coude indicator notch with no issues for 11 of the 14 catheters returned.When catheter 3 was removed from the packaging and laid flat, the coude tip did not appear to align with the indicator notch, however, once the sample was secured with tape and straightened, the tip and notch were aligned.Catheters 4 and 6 were removed from the packaging and laid flat, the coude tip and indicator notch did not appear to be aligned, once straightened and secured with tape the coude tip and indicator notch were still not aligned.A potential root cause for this event could be, "machine error".The device was not used for treatment or diagnostic purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.Correction: g 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: UROLOGICAL CATHETER COUDE TIP
• 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: 15624518
• Report Number: 1018233-2022-07940
• Device Sequence Number: 6470682
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/22/2023

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: 01/31/2026
• Device Model Number: 010114
• Device Catalogue Number: 010114
• Device Lot Number: NGGP0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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