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

Model Number 119314

Device Problems Partial Blockage (1065); No Flow (2991)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that urine was not able to flow from the catheter.

Event Description

It was reported that urine was not able to flow from the catheter.

Manufacturer Narrative

The reported event was confirmed, as manufacturing related.Visual evaluation of the sample noted one opened (without original packaging) lubrsil temperature sensing silicone foley.Visual evaluation noted no obvious defects.The product was used for diagnostic and treatment purposes.Attempted to flush the drainage lumen, however solution would not pass all the way through.The catheter was cut where the solution would not pass and was found to have excess silicone blocking the lumen,.This was out of specification which stated, "visually check that there¿s no material in murphy eye or drainage lumen." although the reported event was confirmed manufacturing related, the root cause could not be determined.A potential root cause for this failure could be "- tooling misalignment.- tooling wear.- silicone inside the lumen.- incorrect use of tool." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." correction: d4 (lot#).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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9089095
• MDR Text Key: 165139062
• Report Number: 1018233-2019-05801
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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: 01/16/2024
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGDN0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1