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

Model Number 175814

Device Problem Component Misassembled (4004)

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

Event Date 02/22/2023

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 balloon on the foley catheter did not inflate symmetrically during training.During training for the bard foley trays in barcelona, a healthcare personnel pointed out that the balloon had not inflated symmetrically.Also stated that it appears that the balloon would not sit in the patient¿s bladder to ensure correct drainage.The catheter had been inserted into an anatomical model.As per additional information received on 22feb2023, stated that when the user was packaging the catheter, they noticed that the tip was not symmetrical and there were some jagged edges sticking out the top.As per follow up information received via ibc on 01mar2023, confirmed that the catheter in the image is the one that was used on anatomical model.

Event Description

It was reported that the balloon on the foley catheter did not inflate symmetrically during training.During training for the bard foley trays in barcelona, a healthcare personnel pointed out that the balloon had not inflated symmetrically.Also stated that it appears that the balloon would not sit in the patient¿s bladder to ensure correct drainage.The catheter had been inserted into an anatomical model.Per additional information received on 22feb2023, stated that when the user was packaging the catheter, they noticed that the tip was not symmetrical and there were some jagged edges sticking out the top.Per follow up information received via ibc on 01mar2023, confirmed that the catheter in the image is the one that was used on anatomical model.

Manufacturer Narrative

The reported event confirmed cause unknown as tip of catheter appeared not straight.Visual evaluation noted received 1 foley tray in opened packaging.Visual inspection noted that the tip of the catheter was asymmetrical and it seemed to be leaning towards one side.Also, received 3 photo samples each showing the end of catheter with a flash present.Each photo shows the flash from a different angle.Based on physical samples the product does not meet specifications, which states "tips should be straight with respect to tube, transition between tube and tip should be smooth according to visual aid." although an exact root cause could not be determined, a potential root cause could be incorrect setup.A review of the dhr did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.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® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16545253
• MDR Text Key: 311325796
• Report Number: 1018233-2023-01756
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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: 175814
• Device Catalogue Number: 175814
• Device Lot Number: NGFX3158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other