MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER TRAY

Model Number	942216
Health Effect - Clinical Code	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.
Event or Problem Description
It was reported that the tip of the water syringe broke off in the inflation port, prior to inflation of the catheter.
Additional Manufacturer Narrative
The reported issue (the tip of the water syringe broke off in the inflation ort prior to inflation of the catheter) was confirmed after visual evaluation.In the pictures it could be seen that the water syringe was broken on the tip.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port." (b)(4).
Event or Problem Description
It was reported that the tip of the water syringe broke off in the inflation port, prior to inflation of the catheter.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6766736
• Report Number: 1018233-2017-04108
• Device Sequence Number: 139110
• Product Code: EZL
• UDI-Device Identifier: 00801741024979
• UDI-Public: (01)00801741024979
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

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: 09/30/2019
• Device Model Number: 942216
• Device Catalogue Number: 942216
• Device Lot Number: NGBQ3615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1