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

Model Number 175814

Device Problem Sharp Edges (4013)

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.

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.

Manufacturer Narrative

The reported event is confirmed manufacturing related as the flash present on the device was larger than the specification range.Visual evaluation noted received 1 foley tray in opened packaging.Visual inspection noted jagged pieces of extra silicon extending out from the tip.Visual evaluation noted received 1 foley tray in opened packaging.Visual inspection noted jagged pieces of extra silicon extending out from the tip.Visual inspection noted that the tip of the catheter was jagged with pieces of extra silicon extending out from the tip.The piece was measured in length to be 0.1060 in on the tip and 0.2080 in on the side of the tip.A large, jagged piece of silicon was measured to be 0.0735 in.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 received the product does not meet specifications according to which states "flash should not be greater than 0.015¿ if flash is detected on inspection, measure with vision system 20x." although an exact root cause could not be determined a potential root cause could be improper cutting method or worn knife.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The 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: 16545347
• MDR Text Key: 311584443
• Report Number: 1018233-2023-01757
• 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: 05/12/2023

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: 05/12/2023
• Supplement Dates FDA Received: 06/02/2023
• 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