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

Model Number	120616
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Consequences Or Impact To Patient (2199)
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 overall diameter of the tiemann catheter was larger than usual.The patient was able to insert the catheter and void.The patient did experienced bleeding; there was no medical intervention.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use¿.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the overall diameter of the tiemann catheter was larger than usual.The patient was able to insert the catheter and void.The patient allegedly experienced bleeding; there was no medical intervention.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: TIEMANN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8932169
• Report Number: 1018233-2019-05116
• Device Sequence Number: 16665917
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGDP2913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1