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

Model Number 1758SI16

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

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 foley catheter had hard plastic with sharp ridge.No harm occurred.

Event Description

It was reported that the foley catheter had a hard plastic with sharp ridge.It was noted that there was no harm to the patient.Per additional information received via email on 07apr2021 it was stated that the foley catheter had a deflated balloon.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (without original package) used silicone foley was received.Visual inspection of the sample noted that there was a large burr on the balloon closer to the tip.A potential root cause for this failure mode could be due to a worn blade.The device did not meet the specifications the product was not used for treatment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

• 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 30014
• MDR Report Key: 11615104
• MDR Text Key: 243809034
• Report Number: 1018233-2021-01878
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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 Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGEW3672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other