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

Model Number	056112
Medical Device Problem Code	Degraded (1153)
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.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 the catheters were cracked and crumbling within the packaging.
Additional Manufacturer Narrative
The reported event was inconclusive.Received 1 urethral catheter packaging only.The evaluation of the returned sample noted that no device was present in the package.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "english bard® urethral catheter warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.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.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.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Units single use manufacturer use by lot number keep away from sunlight do not use if package is damaged do not resterilize authorized representative in the european community caution, consult accompanying documents consult instructions for use sterilized by irradiation or sterilized by ethylene oxide refer to direct unit label for sterilization method utilized caution: federal (usa) law restricts this device to sale by or on the order of a physician.Bard and bardex are trademarks and/or registered trademarks of c.R.Bard, inc.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." corrections: mfr site, concomitant medical products and device evaluated by mfr.
Event or Problem Description
It was reported that the catheters were cracked and crumbling within the packaging.

• 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: 7580326
• Report Number: 1018233-2018-02127
• Device Sequence Number: 13835397
• Product Code: KOD
• UDI-Device Identifier: 00801741033513
• UDI-Public: (01)00801741033513
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 10/31/2021
• Device Model Number: 056112
• Device Catalogue Number: 056112
• Device Lot Number: NGBU0312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1