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

Model Number 175806N

Device Problem Burst Container or Vessel (1074)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

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 two foley catheters were removed from the packaging and allegedly the balloons appeared rough or ruptured.No patient involvement as this was detected prior use.It was further reported that this was an recurring issue.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.Two samples were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment purposes.The product had caused the reported failure.Visual evaluation of the returned sample noted two opened (with no packaging), used silicone foley catheter.Visual inspection of the samples noted both catheters had a tear on the balloon surface with no missing pieces.This was out of specification per inspection procedure which stated, "catheter must not be stretched, wrinkled or deformed." a potential root cause was not known.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that two foley catheters were removed from the packaging and allegedly the balloons appeared rough or ruptured.No patient involvement as this was detected prior use.It was further reported that this was an recurring issue.

• 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 30014
• MDR Report Key: 11044465
• MDR Text Key: 222779663
• Report Number: 1018233-2020-21854
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034268
• UDI-Public: (01)00801741034268
• Combination Product (y/n): N
• PMA/PMN Number: K070508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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 Expiration Date: 09/30/2022
• Device Model Number: 175806N
• Device Catalogue Number: 175806N
• Device Lot Number: NGEU2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other