MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.; LUBRISIL FOLEY CATHETER

Model Number 175816

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem Abdominal Pain (1685)

Event Type  malfunction  

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.

Event Description

It was reported that the catheter was not draining and had to be manipulated in order to drain.The patient reportedly experienced abdominal pain.

Manufacturer Narrative

The reported issue was unconfirmed.Per visual evaluation, no obstructions were observed along the drainage lumen and inflation lumen.During functional evaluation, the catheter was capable of draining without any interruptions or difficulties.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: ¿proper techniques for urinary catheter maintenance.Secure the foley catheter, use the statlock foley stabilization device if provided.Maintain a closed drainage system by utilizing pre-connected, sealed catheter tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient.Routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate.Leave foley catheter in place only as long as needed.".

Event Description

It was reported that the catheter was not draining and had to be manipulated in order to drain.The patient reportedly experienced abdominal pain.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.
• Type of Device: LUBRISIL FOLEY CATHETER
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6780044
• MDR Text Key: 82502350
• Report Number: 1018233-2017-04163
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

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: Health Professional
• Device Expiration Date: 07/05/2021
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGAT4734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2016
• 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