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

Model Number 802010

Device Problem Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the last three containers did not have any iodine.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿missing components¿.A potential root cause for this failure could be "machine speed out of parameters".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿reorder 802030 without catheter sterile: contents of tray are sterile unless package is opened or damaged, except for povidone-iodine swabs which are not terminally sterilized.Bardia and bard are registered trademarks of c.R.Bard, inc.Or an affiliate.C.R.Bard, inc.Covington, ga 30014 800-526-4455 www.Bardmedical.Com packaged in mexico foley catheter insertion tray for 30cc balloon single use only.Do not resterilize.For urological use only.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Pd-50225 4/01 contents: ¿ povidone-iodine swabs ¿ waterproof underpad ¿ drape ¿ 30cc syringe (prefilled with sterile water) ¿ gloves ¿ lubricant ¿ graduated collection container peel apart 1.Remove tray lid.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Open lubricant.Lubricate catheter.6.Open packet of swabs.7.Prep patient with swabs.8.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water.9.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Warning: after use, the product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Released" h11: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.H3 other text : the device was not returned.

Event Description

It was reported that the last three containers did not have any iodine.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9728909
• MDR Text Key: 183954751
• Report Number: 1018233-2020-01152
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741018282
• UDI-Public: (01)00801741018282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 802010
• Device Catalogue Number: 802010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male