MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

Model Number A902916

Device Problem Gel Leak (1267)

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

Event Date 08/23/2022

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 the foley kit was open and was noted that the ky jelly syringe was empty.Stated that the syringe was removed from the field, and a new ky jelly was obtained to insert the foley.There was some stickiness below the syringe in the tray which appeared to be dried out jelly.

Manufacturer Narrative

The reported event was confirmed cause unknown.The device had not met specifications.The product was not used for patient treatment.Visual evaluation of the returned sample noted one opened (without original packaging), lubricating jelly syringe.Visual inspection of the sample noted no lubricating jelly residue inside the syringe.Also, noted no cap on the syringe.This does not meet specification per ip7602974, revision 8 which states "pre-filled syringes must not leak and must have cap in place".The device history record review could not be performed without a lot number.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 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 the foley kit was open and was noted that the ky jelly syringe was empty.Stated that the syringe was removed from the field, and a new ky jelly was obtained to insert the foley.There was some stickiness below the syringe in the tray which appeared to be dried out jelly.As per additional information received via sample form on 14sep2022, stated that while nurse was preparing to place the foley catheter it was noted that the lubricant syringe was empty and a new lubricant was obtained and used to place foley.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® 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: 15347705
• MDR Text Key: 305519431
• Report Number: 1018233-2022-06859
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A902916
• Device Catalogue Number: A902916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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