MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY

Model Number 0165SI18

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183); Failure to Infuse (2340)

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

Event Date 01/30/2023

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 sterilized water could not be injected because the syringe did not engage with the valve.

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 sterilized water could not be injected because the syringe did not engage with the valve.As per investigator notification received on 27mar2023, stated that this complaint was related to faulty syringe.

Manufacturer Narrative

The reported event was confirmed ¿ supplier related due to water leakage at the inflation valve of the catheters during inflating the balloon with a syringe.The affected syringe was manufactured by hanscent.The potential root cause for this failure could be due to a defective tip on the syringe- smaller tip at the taper end caused the water to leak during inflation from supplier.Dhr review is not required.A labeling review is not required as the investigation was confirmed related to supplier issue.  h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that sterilized water could not be injected because the syringe did not engage with the valve.As per investigator notification received on 27mar2023, stated that this complaint was related to faulty syringe.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: FOLEY TRAY
• 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: 16442954
• MDR Text Key: 310286752
• Report Number: 1018233-2023-01224
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI18
• Device Catalogue Number: 900014A
• Device Lot Number: MYGR1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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