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

Model Number	899616
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 tubing could not be attached to the catheter, as the ez-lok sample port was missing.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related, since there were no traces of adhesive on the tubing.Visual evaluation of the returned sample noted one opened (without original packaging), used dome bag connected to the drainage tubing and the original packaging labeling.It was noted that the sample port connector was missing and there were no traces of adhesive solvent residue on the drainage tubing.Missing components were out of specification.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® lubricath® 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, 10cc gloves (2) underpad (waterproof) (3) povidone-iodine swabs¿ specimen container, cap and label 10cc syringe (prefilled with sterile water) to inflate foley catheter only." correction.
Event or Problem Description
It was reported that the tubing could not be attached to the catheter, as the ez-lok sample port was missing.No medical intervention was reported.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8173369
• Report Number: 1018233-2018-06041
• Device Sequence Number: 16842245
• Product Code: EZC
• UDI-Device Identifier: 00801741000287
• UDI-Public: (01)00801741000287
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 01/31/2021
• Device Model Number: 899616
• Device Catalogue Number: 899616S
• Device Lot Number: NGCR0632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1