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

Model Number 175816

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported that the customer experienced a product complaint with product number a942216 at labor & delivery unit.The foley catheter fell out of the patient and the nurse recognized that the tip was missing nghq2185.The customer saved the catheter and it was available to be returned.No patient complication was reported.The customer was concerned about the foley trays and open lot number, they noticed other issues with foley catheters, kink tubing nghg1002 and cut foley catheter nggz1611.These foley catheters were not inserted in patients.They had samples of these trays too.They quarantined lot number all the three lots which had been removed from circulation.After speaking with customer, they pulled about 3 cases and individual foley trays from the floor.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the customer experienced a product complaint with product number (b)(6)at labor & delivery unit.The foley catheter fell out of the patient and the nurse recognized that the tip was missing (b)(6).The customer saved the catheter and it was available to be returned.No patient complication was reported.The customer was concerned about the foley trays and open lot number, they noticed other issues with foley catheters, kink tubing (b)(6)and cut foley catheter (b)(6).These foley catheters were not inserted in patients.They had samples of these trays too.They quarantined lot number all the three lots which had been removed from circulation.After speaking with customer, they pulled about 3 cases and individual foley trays from the floor.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is within specification as the reported failure could not be reproduced.The product was used for patient treatment or diagnosis.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.Visual: visual evaluation of the returned sample noted one opened (without original packaging), 2-way catheter with attached sample port and inlet tubing.Visual inspection noted no breakage or defects on the catheter.The tip of the catheter was intact.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted, returning 10ml of solution.The balloon passively deflated with no cuffing or leaks noted.The drainage lumen was flushed with d.I.Water.And flowed through with no issues or leaks noted.This is within specification per inspection procedure, which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A device history record review was not required as the investigation was unconfirmed.The reported event is unconfirmed neither a risk review nor labeling review is required.Correction: d,h 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: 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: 17371295
• MDR Text Key: 319526850
• Report Number: 1018233-2023-05400
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• 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: 08/16/2023

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: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGHQ2185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• 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