MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER; RED RUBBER CATHETER

Model Number	0103SI18
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 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.The device was not returned.
Event or Problem Description
It was reported that urine did not drain through the drainage eye, and would go around the catheter unless the catheter was repeatedly pulled.Complainant reportedly used a razor blade to cut an additional drainage eye in the catheter.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: on catheter, do not use ointments or lubricants having petrolatum base.Recommended inflation capacities: 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.30cc balloon: use 35cc sterile water.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter related adverse effect, the catheter should be replaced.Do not exceed recommended capacities." the device was not returned.
Event or Problem Description
It was reported that urine did not drain through the drainage eye, and would go around the catheter unless the catheter was repeatedly pulled.Complainant reportedly used a razor blade to cut an additional drainage eye in the catheter.

• Brand Name: BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: RED RUBBER CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7923887
• Report Number: 1018233-2018-04502
• Device Sequence Number: 1936849
• Product Code: MJC
• UDI-Device Identifier: 00801741017148
• UDI-Public: (01)00801741017148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• 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): 01/03/2019

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: 12/31/2020
• Device Model Number: 0103SI18
• Device Catalogue Number: 0103SI18
• Device Lot Number: NGBW1283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1