MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER

Model Number 0165L16

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 urine would not drain from the catheter and the nursing staff was unable to flush the catheter.The patient was allegedly given additional medication during the procedure and the catheter was replaced.

Event Description

It was reported that urine would not drain from the catheter and the nursing staff was unable to flush the catheter.The patient was allegedly given additional medication during the procedure and the catheter was replaced.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.Received 1 used temperature sensing foley catheter with the original packaging for evaluation.Per visual evaluation no defects on the catheter were found.Per the functional evaluation, a flow test was performed.The unit was considered acceptable if it drained 250cc of water according to the following flow rate: french size unused used 16 fr.64 seconds maximum must drain.There was no water flow through the catheter noted and obstruction of silicone in the drainage lumen was found.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: "inaccurate flow rate: caution: do not aspirate urine through drainage funnel wall.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING 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: 7264792
• MDR Text Key: 99857576
• Report Number: 1018233-2018-00430
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741017483
• UDI-Public: (01)00801741017483
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: 0165L16
• Device Catalogue Number: 119216M
• Device Lot Number: NGBV3104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention