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

Model Number	010118
Medical Device Problem Codes	Material Twisted/Bent (2981); Component Misassembled (4004)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/24/2021
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 bard 18fr urological catheter was twisted and the guiding nib did not line up with the coude tip.It was stated that it was difficult to ensure the catheter tip was pointing up and there were 17 catheters from a 10 box order.The patient had experienced pain and bleeding.No medical intervention was reported.
Event or Problem Description
It was reported that the bard 18fr urological catheter was twisted and the guiding nib did not line up with the coude tip.It was stated that it was difficult to ensure the catheter tip was pointing up and there were 17 catheters from a 10-box order.The patient had experienced pain and bleeding.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.One sample was confirmed to exhibit the reported failure.Received 9 orange urological catheters unopened in original packaging.3 catheters were selected at random for testing via sampling plan.The first catheter appeared to have a misaligned coude tip.Once the catheter was straightened the coude tip and indicator where aligned.The second and third catheters both had coude indicators that aligned with the tip before and after straightening.The reported event is confirmed, as bends in the first catheter, made the coude indicator appear unaligned with the tip.A potential root cause for this failure could be "operator or machine error.Although there is currently no specification regarding coude tip indicator alignment, the device does not meet specification as the device is intended to have a coude curve aligning with the coude indicator.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as the reported event was confirmed as manufacturing related.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: TIEMANN MODEL UROLOGICAL 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11662184
• Report Number: 1018233-2021-02104
• Device Sequence Number: 2899748
• Product Code: KOD
• UDI-Device Identifier: 00801741029882
• UDI-Public: (01)00801741029882
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Expiration Date: 09/30/2024
• Device Model Number: 010118
• Device Catalogue Number: 010118
• Device Lot Number: NGEU0477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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