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

Model Number	120616
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Pain (1994)
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 tip of the tiemann catheter was more round than usual.The patient experienced pain while using the catheter.No patient injury was reported.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturer related.The sample was received opened and with the original packaging.The sample was in good condition.Visual observation noted the indicator dot was not in alignment with the coude curve and the tip was rounded, and somewhat bulbous.The device was measured using a french gauge and the widest portion of the tip measured 15 fr.The shaft of the catheter was measured 17 fr.Which falls with in the permissible french size of +/- 1 fr of the intended french size.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.".
Event or Problem Description
It was reported that the tip of the tiemann catheter was more round than usual.The patient experienced pain while using the catheter.No patient injury was reported.

• Brand Name: BARD® TIEMANN MODEL URETHRAL CATHETER COUDE TIP
• Common Device Name: TIEMANN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8356663
• Report Number: 1018233-2019-00909
• Device Sequence Number: 19266124
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 10/31/2022
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGCS1268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1