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

Model Number	056032
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	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.The device was not returned.
Event or Problem Description
It was reported that the catheter was thicker and stiffer than usual.The complainant allegedly was unable to insert the catheter.
Event or Problem Description
It was reported that the catheter was thicker and stiffer than usual.The complainant allegedly was unable to insert the catheter.
Additional Manufacturer Narrative
The reported event was inconclusive.The evaluation of the photo sample could not determine any device characteristics related to the reported event of thick diameter.The dimensional and functional evaluation of the device was not possible without receipt of the original sample.Visual evaluation of the photo sample noted no obvious defect.The devices were not used and were in original packaging.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.Bard and bardex are trademarks and/or registered trademarks of c.R.Bard, inc.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.".

• Brand Name: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: ROBINSON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7970900
• Report Number: 1018233-2018-04794
• Device Sequence Number: 202080
• Product Code: KOD
• UDI-Device Identifier: 00801741033483
• UDI-Public: (01)00801741033483
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 01/31/2019
• Device Model Number: 056032
• Device Catalogue Number: 056032
• Device Lot Number: NGYF2486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1