MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN DUAL LUMEN CV CATHETER, 7F; CHRONIC CATHETERS

Model Number 0600574

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2025).Device pending return.

Event Description

It was reported that during a chronic catheter placement procedure in the right internal jugular, the patient allegedly experienced air embolism.It was further reported that medical interventions was required to remove air embolism through medications.The patient reportedly to be stable.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instructions for use states that, warning: do not use the catheter if there is any evidence of mechanical damage or leaking.Accessories and used in conjunction with this device should incorporate luer lock connectors.Avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth edge atraumatic clamps or forceps.Avoid perforating, tearing or fracturing the catheter when using a guidewire.Prior to beginning placement procedure, do the following: examine package carefully before opening to confirm its integrity and that the expiration date has not passed.The device is supplied in a double sterile package and is non-pyrogenic.Do not use if package is damaged, opened or the expiration date has passed.(product is) sterilized by ethylene oxide.Do not resterilize.Inspect kit for inclusion of all components.Do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumens.If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter.Clamping the catheter.Selection of the catheter clamp is very important since the catheter is vital to your care.The wrong clamp can damage the catheter.Follow these three rules for clamping: 1.Use only smooth-edged clamps.2.Always clamp the catheter over the reinforced clamping sleeve or tape tab, as instructed by your nurse.Never clamp over the reinforced segment directly adjacent to the connector.(see diagram) 3.Follow the directions of your doctor or nurse regarding when to clamp.Most hickman and broviac catheters come with pre-attached clamps and reinforced clamping sleeves - do not clamp here.H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

It was reported that during a chronic catheter placement procedure, the device allegedly had bubbles in the line.The procedure was completed using another device.Reportedly medical intervention required for air embolism.The current patient status was unknown.

• Brand Name: HICKMAN DUAL LUMEN CV CATHETER, 7F
• Type of Device: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14496965
• MDR Text Key: 292613418
• Report Number: 3006260740-2022-01946
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051876
• UDI-Public: (01)00801741051876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600574
• Device Catalogue Number: 0600574
• Device Lot Number: HUEX1783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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): Required Intervention