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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 7F; CHRONIC CATHETER Back to Search Results
Model Number 0600570
Device Problems Fluid/Blood Leak (1250); Expulsion (2933)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2022
Event Type  malfunction  
Event Description
It was reported that fifteen days post chronic catheter placement procedure, the catheter allegedly had displaced out from its insertion site.It was further reported that the saline allegedly leaked from its insertion site.Reportedly the catheter was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2026).
 
Event Description
It was reported that fifteen days post chronic catheter placement procedure, the catheter allegedly had displaced out from its insertion site.It was further reported that the saline allegedly leaked from its insertion site.Reportedly the catheter was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
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.The definitive root cause could not be determined based upon 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 cleaning.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.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.D4 (expiry date: 07/2026).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.
 
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Brand Name
HICKMAN CV CATHETER, DUAL-LUMEN, 7F
Type of Device
CHRONIC CATHETER
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 Key15985864
MDR Text Key308137947
Report Number3006260740-2022-05747
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741051869
UDI-Public(01)00801741051869
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K830233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0600570
Device Catalogue Number0600570
Device Lot NumberHUGP1772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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