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	08/17/2022
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 the straight tip catheters were causing the patient to bleed and they was not able to use them.Patient had spoken to doctor and switched to coude tip.Patient had been using the products for more than 90 days.No medical intervention was reported.Per investigator notification received on (b)(6) 2022.It was stated that the customer returned urological catheter coude tip with material number 010114 and batch number ngfw1717 for this complaint.Per investigator notification on (b)(6) 2022, it was found that excessive flash was present within the eyelet of one catheter and the coude tip did not align with the coude indicator on one catheter.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.A total of 72 unopened tiemann coude catheters were returned.Seven samples were selected at random per the c=0 sampling plan.The surface of the catheters was observed to be smooth.Using a french gauge, all catheters were confirmed to be 14fr, meeting specifications.All catheters met specifications it states, "accept any curve unless catheter is completely straight." the coude curve aligned with the coude indicator bump for 6 of the 7 catheters.Some degradation due to oxidation was noted at the tip and within the drainage eye of catheter 1 as well as within the drainage eye of catheters 2, 4, and 5, as this was not reported by the customer and it is unknown when the oxidation occurred or how the catheter was being stored, a new complaint will not be created.Catheter 3 was observed to have excess flash within the eyelet.When catheter 4 was removed from the packaging, the catheter appeared twisted as the coude tip and indicator did not align; once secured with tape the coude tip and indicator were still not aligned.The eye dimensions were measured and found to be within specifications.The catheters were individually connected to the di fountain to check for proper drainage.All seven catheters drained freely and showed no signs of blockage.Based on the risk document a potential root cause for this event could be, "operator error".The samples were returned unopened; therefore, were not used on a patient, however, are intended for treatment purposes.The device history record was reviewed and no manufacturing issues or non-conformances were noted during review of the dhr that could have 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.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 or Problem Description
It was reported that the straight tip catheters were causing the patient to bleed, and they were not able to use them.Patient had spoken to doctor and switching to coude tip.The patient had been using the products for more than 90 days.No medical intervention was reported.Per investigator notification received on 02mar2022.It was stated that the customer returned urological catheter coude tip with material number 010114 and batch number ngfw1717 for this complaint.Per investigator notification on 17aug2022, it was found that burn residue was present within the eyelet of one catheter and the coude tip did not align with the coude indicator on one catheter.

• 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: 15293396
• Report Number: 1018233-2022-06654
• Device Sequence Number: 2658218
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: 010114
• Device Catalogue Number: 010114
• Device Lot Number: NGFW1717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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