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

Model Number 175814

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); 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.

Event Description

It was reported that the catheter fell out of the patient with the balloon still in tact.The catheter was reportedly in use for a few hours.

Manufacturer Narrative

The reported event was unconfirmed, since the reported failure could not be reproduced.The product was used for treatment purposes.The device met specifications.Visual evaluation of the silicone noted one opened silicone foley with balloon inflated without original packaging.Visual inspection of the sample noted no obvious defects.The 7cc solution was removed from catheter.The catheter balloon was re-inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) balloon concentricity was observed to be 70:30.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.The drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) with no leaks.Active length of the catheter balloon was measured ( 0.6990") and found to be within specification (0.6-0.9 inches).The catheter was confirmed to be size 14 fr.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: ¿recommended inflation capacities 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.30cc balloon: use 35cc sterile water.Do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters." 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.

Event Description

It was reported that the catheter fell out of the patient with the balloon still in tact.The catheter was reportedly in use for a few hours.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE 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: 9137046
• MDR Text Key: 179508381
• Report Number: 1018233-2019-06073
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: 175814
• Device Catalogue Number: 175814
• Device Lot Number: NGDQ3165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1