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

Model Number	897216
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 device was not returned.
Event or Problem Description
It was reported that the silicone catheter tray was missing the lubrication syringe.
Event or Problem Description
It was reported that the silicone catheter tray was missing the lubrication syringe.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: "contents: ¿ bardex 5cc all-silicone foley catheter 2000ml (approx.Vol.) capacity drainage bag with anti-reflux chamber bard ez-lok® sampling port string hanger attached sheeting clip control-fittm outlet device ¿ tamper-evident seal ¿ uro-preptm tray with: catheter lubricating jelly syringe latex-free, powder-free gloves (2) underpad (waterproof), drape forceps, prep balls (5) povidone-iodine solution 10cc syringe (prefilled with sterile water) to inflate foley catheter only.¿ specimen container, cap and label".Section a through f - the information provided by bd 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 bd.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8344472
• Report Number: 1018233-2019-00847
• Device Sequence Number: 207035
• Product Code: EZL
• UDI-Device Identifier: 00801741020322
• UDI-Public: (01)00801741020322
• Combination Product (Y/N): N
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 03/31/2021
• Device Model Number: 897216
• Device Catalogue Number: 897216
• Device Lot Number: NGCT4263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1