MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS

Model Number 0600540

Device Problems Burst Container or Vessel (1074); Fracture (1260); Stretched (1601); Obstruction of Flow (2423); Material Protrusion/Extrusion (2979)

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

Event Date 12/09/2022

Event Type  malfunction  

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: 06/2025) device pending return.

Event Description

It was reported that during a chronic catheter placement procedure, the catheter allegedly ballooned while inside the patient and had to be removed.There was no reported patient injury.

Event Description

It was reported that during a catheter placement procedure, the catheter allegedly ballooned while inside the patient and had to be removed.It was further reported that catheter was allegedly occluded.There was no reported patient injury.

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: one hickman s/l catheter in two segments were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluation and destructive testing were performed.Also one electronic photo was provided for review.A complete diagonal break was noted on the proximal end and a complete circumferential break was noted on the distal end of the catheter segment.The edges of the complete diagonal break were noted to be uneven.The surface was noted to be glossy with striations throughout.Residue was noted throughout the surface as well.The edges of the complete diagonal break and the complete circumferential break were noted to be uneven and the surface was noted to be glossy with striations throughout.Upon infusion, ballooning was observed throughout the clamping sleeve and a small leak was observed.What appeared to be a compound split, was noted on the inner catheter, proximal to the luer.Therefore the investigation is confirmed for the reported material protrusion, stretched issue and identified fracture and burst issue.However the investigation is inconclusive for the reported obstruction of flow issue as exact circumstances at the time of the reported event was unknown and cannot verified from the provided photos.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 was reviewed.The instructions for use that was included with the product prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.On site care instructions states to use alcohol wipes during cleanings.This instructions for use warns: 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.¿pinch-off prevention: catheters placed percutaneously or through a cut-down, into the subclavian vein, should be inserted at the junction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet.The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even severance of the catheter.A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.¿ ¿use aseptic techniques whenever the catheter lumen is opened or connected to other devices.Povidone-iodine is the suggested antiseptic to use with this device and components.Acetone and tincture of iodine should not be used because they could adversely affect the performance of the catheter and connectors.10% acetone/ 70% isopropyl alcohol swabsticks used for dressing changes should not adversely affect the catheter.¿ ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).¿ ¿accessories and components used in conjunction with this device should incorporate luer lock connections.¿ ¿catheter damage if the catheter or connection is damaged or dislodged during or after surgery, immediately clamp the catheter with an atraumatic catheter clamp or kink and tape it.The catheter should be repaired as soon as possible using the designated hickman*, leonard* and broviac* repair kit for that particular catheter size.Instructions are enclosed in the repair kit package and are also available in the hickman*, leonard* and broviac* catheter nursing procedure manual.¿ ¿site care coil the catheter, check to see that it is not kinked or pinched, and secure it to the chest or dressing with tape.This will prevent pulling of the catheter at the exit site and decrease irritation.¿ ¿flushing the catheter and ¿heparin lock¿.Procedure: supplies you will need: alcohol or povidone iodine wipe; 10ml syringe with attached 1 inch needle filled with 2.5 ml of heparin, prepared for use; clamp; tape.The steps in the procedure are: collect your supplies in a convenient place.Wash your hands thoroughly.Remove the tape that is around the injection cap.Clean the cap with an alcohol or povidone iodine wipe.If you use the iodine wipe, allow the cap to air dry for two minutes ¿ be sure not to touch the cap during this time.Do not blow on the area or allow the clean cap to dangle since this increases the chance of contamination of the area with germs.Remove the needle cover and carefully insert the needle into the center of the catheter injection cap.Release the clamp.Inject the heparin into the catheter.As you inject the last 0.5 ml of heparin solution, withdraw the needle from the injection cap.If you are flushing the catheter of a child, do not flush too rapidly because the child¿s circulatory system is small and sensitive to rapid changes in volume and pressure.Remove the needle from the injection cap.Discard the syringe and needle in a biohazard container.Retape the cap as outlined in the injection cap change procedure.¿ h10: (expiry date: 06/2025).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.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
• 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 REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16081920
• MDR Text Key: 306883265
• Report Number: 3006260740-2022-05954
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• UDI-Public: (01)00801741051821
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600540
• Device Catalogue Number: 0600540
• Device Lot Number: HUEU1562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• 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