MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER

Model Number 33618

Device Problem Device Slipped (1584)

Patient Problem 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 catheter fell out after insertion.The status of the balloon inflation is unknown.The catheter was inserted by a nurse and has been returned to the store of purchase.

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 state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Event Description

It was reported that the catheter fell out after insertion.The status of the balloon inflation is unknown.The catheter was inserted by a nurse and has been returned to the store of purchase.

Manufacturer Narrative

The reported issue was unconfirmed.The device was returned and visually inspected.The exterior of the sample did not show anything to contribute to the reported event.The balloon was inflated with air while submerged in water and found the balloon did not deflate.Unable to duplicate reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Event Description

It was reported that the catheter fell out after insertion.The status of the balloon inflation was unknown.The catheter was inserted by a nurse and has been returned to the store of purchase.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6951972
• MDR Text Key: 89579910
• Report Number: 1018233-2017-05276
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070
• Combination Product (y/n): N
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 33618
• Device Catalogue Number: 33618
• Device Lot Number: AP5296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1