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

Catalog Number 1758SI16

Device Problems Break (1069); Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/06/2018

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 balloon was damaged and fell out of the patient's body on the 8th day of usage.It was later reported that the patient was bed-ridden.After pretest was performed, the catheter was inserted into the patient for urine drainage at a ward.There was no pieces remaining in the patient's body.

Event Description

It was reported that the balloon was damaged and fell out of the patient's body on the 8th day of usage.It was later reported that the patient was bed-ridden.After pretest was performed, the catheter was inserted into the patient for urine drainage at a ward.There was no pieces remaining in the patient's body.

Manufacturer Narrative

The reported issue was confirmed.Per visual evaluation, the balloon was found to have a burst and no pieces missing were noted.Per the dimensional evaluation of active length, the catheter was manufactured within the specifications.Active length was measure and results are as follows: short side= 0.7135¿, long side= 0.7630¿ (per 1067b the active length is 0.6¿ to 0.9¿).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: "recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use.".

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7505222
• MDR Text Key: 107977569
• Report Number: 1018233-2018-01629
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 07/12/2018

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: 09/01/2021
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGAU1854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1