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

Model Number	0094160
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the eyelets on the catheter were too sharp.The complainant reported that the portion of the eyelets closest to the tip was noted to be the sharpest.
Additional Manufacturer Narrative
The reported event was unconfirmed since the sample met specifications.Ten samples were received open and without the original packaging.Visual observation noted no defects, burrs, or sharp lumps and the eye location was also evaluated.Visual standards for eye scoring, burning, and flashing were used to evaluate the quality of the eye and all samples were unconfirmed for the reported event.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿davol®all-purpose urethral catheter 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.U.S.Product.Packaged in mexico caution: federal (usa) law restricts this device to sale by or on the order of a physician.Single use contains or presence of natural rubber latex.Lot number catalog number do not resterilize.Caution, consult accompanying documents.Do not use if package is damaged units keep away from sunlight warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Consult instructions for use.Sterilized using ethylene oxide bard and davol are trademarks and/or registered trademarks of c.R.Bard, inc.".
Event or Problem Description
It was reported that the eyelets on the catheter were too sharp.The complainant reported that the portion of the eyelets closest to the tip was noted to be the sharpest.

• Brand Name: BARD® ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8200881
• Report Number: 1018233-2018-06220
• Device Sequence Number: 11170527
• Product Code: KOD
• UDI-Device Identifier: 00801741034039
• UDI-Public: (01)00801741034039
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/28/2019

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 Model Number: 0094160
• Device Catalogue Number: 0094160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1