MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TOOMEY IRRIGATION SYRINGE WITH CATHETER TIP AND LUER TIP ADAPTERS; TOOMEY SYRINGE

Model Number 0038460

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the customer needed toomey irrigation syringe with a cap.Stated that they placed barium in it and was leaking out of the syringe during the procedure.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the customer needed toomey irrigation syringe with a cap.Stated that they placed barium in it and was leaking out of the syringe during the procedure.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿improper dimension or tolerancing¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.¿ 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 needed toomey irrigation syringe with a cap.Stated that they placed barium in it and was leaking out of the syringe during the procedure.

• Brand Name: TOOMEY IRRIGATION SYRINGE WITH CATHETER TIP AND LUER TIP ADAPTERS
• Type of Device: TOOMEY SYRINGE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13546606
• MDR Text Key: 285995300
• Report Number: 1018233-2022-00670
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049316
• UDI-Public: (01)00801741049316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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: 0038460
• Device Catalogue Number: 0038460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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