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

Model Number	0094100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
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 when the rn was treating a bladder patient and started to push in the solution, a small spray, allegedly, came out of the side of the catheter a few inches down from the proximal end.The patient needed to be re-catheterized with another catheter.
Event or Problem Description
It was reported that when the rn was treating a bladder patient and started to push in the solution, a small spray, allegedly, came out of the side of the catheter a few inches down from the proximal end.The patient needed to be re-catheterized with another catheter.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿leakage¿ with a potential root cause of "poor interface between the catheter shaft and the drainage funnel/handle".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: "caution: this product contains natural rubber latex which may cause allergic reactions.With funnel end 16¿ (40.6cm) length, two eyes, x-ray opaque rubber warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.".

• Brand Name: BARD® ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9394853
• Report Number: 1018233-2019-07624
• Device Sequence Number: 10908912
• Product Code: KOD
• UDI-Device Identifier: 00801741034008
• UDI-Public: (01)00801741034008
• 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: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 0094100
• Device Catalogue Number: 94100
• Device Lot Number: NGDS0381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1