MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY CATHETER SILICONE COATED; SILICONE FOLEY CATHETER

Model Number	265716
Health Effect - Clinical Code	No Information (3190)
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.
Event or Problem Description
It was reported that the catheters appeared to be the incorrect size.
Additional Manufacturer Narrative
Received 1 foley catheter.The reported event was unconfirmed.Per the visual inspection, the exterior of the sample was inspected and did not find any evidence of a failure that would support the reported event.Per the dimensional evaluation, the sample was evaluated and the shaft and tip thickness of returned sample was measured and found to be within specification.As per specification, the catheters are manufactured with tolerance of ± 1fr.Based on evaluation, returned catheters manufactured per manufacturing specification and found within specification.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: "visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water or for prefilled products, remove clips and squeeze reservoir to inflate with stated ml of sterile water." (b)(4).
Event or Problem Description
It was reported that the catheters appeared to be the incorrect size.
Event or Problem Description
It was reported that the catheters appeared to be the incorrect size.
Additional Manufacturer Narrative
Received 1 foley catheter.The reported event was unconfirmed.Per the visual inspection, the exterior of the sample was inspected and did not find any evidence of a failure that would support the reported event.Per the dimensional evaluation, the sample was evaluated and the shaft and tip thickness of returned sample was measured and found to be within specification.As per specification, the catheters are manufactured with tolerance of ± 1fr.Based on evaluation, returned catheters manufactured per manufacturing specification and found within specification.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: "visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water or for prefilled products, remove clips and squeeze reservoir to inflate with stated ml of sterile water." (b)(4).

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6890805
• Report Number: 1018233-2017-04943
• Device Sequence Number: 13628227
• Product Code: EZC
• UDI-Device Identifier: 00801741039591
• UDI-Public: (01)00801741039591
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2018

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: 09/28/2021
• Device Model Number: 265716
• Device Catalogue Number: 265716
• Device Lot Number: 6LZ8154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 03/01/2018
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 01/11/2018; 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1