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

Model Number	802130
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
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 one of the insertion trays were opened on the last order, so they threw the tray away and did not use it due to risk of infection.
Event or Problem Description
It was reported that one of the insertion trays were opened on the last order so the patient thrown the tray away and did not use it due to the risk of infection.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to insufficient package design that did not protect the product from elements during shipping and storage.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: 1) remove tray lid 2) place under pad 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 over penetrate) 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 reseat 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.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product." the device was not returned.

• Brand Name: BARDIA FOLEY CATHETER INSERTION TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11012932
• Report Number: 1018233-2020-21702
• Device Sequence Number: 4242458
• Product Code: OHR
• UDI-Device Identifier: 00801741018275
• UDI-Public: (01)00801741018275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: Lay User/Patient
• Device Model Number: 802130
• Device Catalogue Number: 802130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other