MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ADD-A-FOLEY TRAY; BARDEX IC TRAY

Model Number	399400A
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 kit was missing the tubing that connects the drain bag to the catheter.
Event or Problem Description
It was reported that the kit was missing the tubing that connects the drain bag to the catheter.
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 was found adequate and states the following: "contents: urine collection system ref 399400a without catheter without catheter c.R.Bard, inc.Covington, ga 30014 ¿ 1.800.526.4455 www.Bardmedical.Com manufactured and packaged in mexico pk7634287 03/2011 string hanger, attached sheeting clip, underpad, fenestrated drape, latex-free gloves, 3 antiseptic swab sticks, 10cc lubricating jelly syringe, prefilled 10cc syringe of sterile water, specimen container with cap and label, hand sanitizer, castile soap towelettes bard® infection control add-a-foley tray with statlock® stabilization device and bacteriostatic collection system with statlock® stabilization device and bacteriostatic collection system bard ® infection control add-a-foley tray bard, control-fit, ez-lok, and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.Caution, consult accompanying documents.Single use do not use if package is damaged do not resterilize sterile unless package is open or damaged, except for the hand sanitizer and castile soap towelettes which are not terminally sterilized.Ref 399400a statlock® foley catheter stabilization device ez-lok® needleless urine sample port bacteriostatic drainage tube bacteriostatic collection bag anti-reflux chamber anti-microbial control-fit¿ outlet device".

• Brand Name: BARD® ADD-A-FOLEY TRAY
• Common Device Name: BARDEX IC TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7828873
• Report Number: 1018233-2018-03852
• Device Sequence Number: 19252228
• Product Code: KNX
• UDI-Device Identifier: 00801741024290
• UDI-Public: (01)00801741024290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 06/30/2020
• Device Model Number: 399400A
• Device Catalogue Number: 399400A
• Device Lot Number: NGBX0046
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1