MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE

Model Number 303416A

Device Problem Gel Leak (1267)

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

Event Date 08/19/2022

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 there was no lubricant in the lubricant jelly syringe.It was also stated that the syringe that was supposed to contain saline did not have a plunger and therefore there was no saline.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual inspection noted lubricant residue in the lubricant jelly syringe.Although an exact root cause could not be determined a potential root cause could be improper grommet fit within barrel resulting in blow-by/spillage of lube.Dhr review was not conducted as a lot number was not provided.Labelling review is not required as labelling would not have prevented the reported event.The actual/suspected device was evaluated.

Event Description

It was reported that there was no lubricant in the lubricant jelly syringe.It was also stated that the syringe that was supposed to contain saline did not have a plunger and therefore there was no saline.Per additional information received via sample form on 01sep2022, it was stated that when nurse was prepping to insert catheter, upon inspection of the kit prior to insertion, it was noted that there was no lube in the lube syringe and sterile saline syringe had no plunger.Another tray was opened and used without any issue.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE
• 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: 15335082
• MDR Text Key: 305047792
• Report Number: 1018233-2022-06816
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 303416A
• Device Catalogue Number: 303416A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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